PLAS-TECH ENGINEERING, LLC

FDA Device Registration & Listing · Lake Geneva, WI, US · Registration 3003589911

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003589911
FEI Number
3003589911
Entity Name
PLAS-TECH ENGINEERING, LLC
City/State/Country
Lake Geneva, WI, US
Establishment Address
875 GENEVA PKWY N, Lake Geneva, WI 53147, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Plas-Tech Engineering, LLC (Owner Number: 10046205)
Owner / Operator Contact Address
875 Geneva Parkway N, Lake Geneva, WI 53147, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cap DD AHS NHS SP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2019-12-27
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2018-12-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-12-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2019-12-27
PZW Catheter Access Cover, Tamper-Resistant General Hospital Class 2 880.5970 2025-03-04

Official Correspondent

Chris Swanson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Plas-Tech Engineering, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number Establishment Name Location
3013319212 ICU MEDICAL, INC. Lake Forest, IL, US
3031757047 Solventum US LLC Brookings, SD, US
1713468 ICU MEDICAL, INC Salt Lake City, UT, US
1423662 Sterigenics US LLC Gurnee, IL, US
3036497156 Solventum US LLC Columbia, MO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003589911. Last updated year: 2026. Please use registration number 3003589911 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.