SPECIALITY PHARMA MFG

FDA Device Registration & Listing · Carlstadt, NJ, US · Registration 3015282703

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
3015282703
FEI Number
3015282703
Entity Name
SPECIALITY PHARMA MFG
City/State/Country
Carlstadt, NJ, US
Establishment Address
611 Industrial Road, Carlstadt, NJ 07072, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Speciality Pharma Mfg (Owner Number: 10083144)
Owner / Operator Contact Address
611 Industrial Road, Carlstadt, NJ 07072, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EMT/Hycol/Collasate/Cellerate Collagen Silver Gel SilvaKollagen Gel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2021-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2021-10-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2021-10-28

Official Correspondent

James Geraghty

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Speciality Pharma Mfg
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
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
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 3015282703. Last updated year: 2026. Please use registration number 3015282703 when referencing this establishment in official correspondence.
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