SUMMERS LABORATORIES INC.

FDA Device Registration & Listing · Collegeville, PA, US · Registration 1000121375

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
1000121375
FEI Number
1000121375
Entity Name
SUMMERS LABORATORIES INC.
City/State/Country
Collegeville, PA, US
Establishment Address
103 GP Clement Drive, Collegeville, PA 19426, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Summers Laboratories Inc. (Owner Number: 10090292)
Owner / Operator Contact Address
103 GP Clement Drive, Collegeville, PA 19426, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K113693
PMA Number
N/A

All Registered Proprietary Names

HypoCyn

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-03-08

Official Correspondent

Linda Czeiner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Summers Laboratories Inc.
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
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000121375. Last updated year: 2026. Please use registration number 1000121375 when referencing this establishment in official correspondence.
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