HARBOR MEDTECH, INC.

FDA Device Registration & Listing · Lake Forest, CA, US · Registration 3010097129

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
3010097129
FEI Number
3010097129
Entity Name
HARBOR MEDTECH, INC.
City/State/Country
Lake Forest, CA, US
Establishment Address
21076 Bake Parkway, Suite 100, Lake Forest, CA 92630, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Harbor MedTech, Inc. (Owner Number: 10090866)
Owner / Operator Contact Address
21076 Bake Parkway, Suite 100, Lake Forest, CA 92630, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140367
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2026-01-15

Official Correspondent

Jerry Mezger

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Harbor MedTech, 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010097129. Last updated year: 2026. Please use registration number 3010097129 when referencing this establishment in official correspondence.
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