PURETEK CORPORATION

FDA Device Registration & Listing · Panorama City, CA, US · Registration 3012818008

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
3012818008
FEI Number
3012818008
Entity Name
PURETEK CORPORATION
City/State/Country
Panorama City, CA, US
Establishment Address
7900 NELSON RD STE A, Panorama City, CA 91402, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PureTek Corporation (Owner Number: 10052870)
Owner / Operator Contact Address
7900 Nelson Road, Suite A, Panorama City, CA 91402, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Silagel DermacinRx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PFP Silicone Hydrogel For Scar Management General, Plastic Surgery Class 1 878.4025 2020-12-22
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2020-04-09
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2020-05-18

Official Correspondent

Elaine Matic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PureTek Corporation
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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012818008. Last updated year: 2026. Please use registration number 3012818008 when referencing this establishment in official correspondence.
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