AZAC Group

FDA Device Registration & Listing · City of Industry, CA, US · Registration 3017494520

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
3017494520
FEI Number
3017494520
Entity Name
AZAC Group
City/State/Country
City of Industry, CA, US
Establishment Address
17870 Castleton St STE 121, City of Industry, CA 91748, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
AZAC Group (Owner Number: 10078199)
Owner / Operator Contact Address
17870 Castleton St STE 121, City of Industry, CA 91748, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K211538
PMA Number
N/A

All Registered Proprietary Names

ProtectX ProtectX Plastic Disposable Gown AAMI Level 3 Protective Gown

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-10-26
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-10-26
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-10-14
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2022-02-21

Official Correspondent

Yen-Ping Shan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AZAC Group
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
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017494520. Last updated year: 2026. Please use registration number 3017494520 when referencing this establishment in official correspondence.
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