Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008770963

FEI Number

3008770963

Entity Name

HUMAN BIOSCIENCES, INC.

City/State/Country

Martinsburg, WV, US

Establishment Address

600 N Queen St, Martinsburg, WV 25404, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Human Biosciences, Inc. (Owner Number: 10034299)

Owner / Operator Contact Address

600 N Queen St, Martinsburg, WV 25404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012990

PMA Number

N/A

All Registered Proprietary Names

Medifil II MF2002 Medifil II MF2001 Collatek Collagen Gel Cellufil CF2001 Cellufill CF2001 Cellusheet CS1077 Cellusheet CS1022 SkinTemp II ST1022 SkinTemp II ST1077 SkinTemp II ST1002 Collecule LpH Collagen Pad CSP1045 SkinTemp II ST10510 SkinTemp II ST1003 SkinTemp II ST1045 Celluheal Calcium Alginate Dressing Collecule LpH Surgical Collagen Powder CSP1050 Collecule LpH Surgical Collagen Powder CSP1001

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	2010-11-22
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2010-11-22
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2018-07-06
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-05-13
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2013-12-23
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-05-31
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-03-14

Official Correspondent

Rohan Jain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Human Biosciences, 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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

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3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008770963. Last updated year: 2026. Please use registration number 3008770963 when referencing this establishment in official correspondence.