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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K250329
Device Name GeniPhys Collymer Self-Assembling Scaffold
Applicant
Geniphys, Inc.
7750 Zionsville Rd., Suite 200
Indianapolis,  IN  46268
Applicant Contact Sherry Harbin
Correspondent
Geniphys, Inc.
7750 Zionsville Rd., Suite 200
Indianapolis,  IN  46268
Correspondent Contact Sherry Harbin
Classification Product Code
KGN  
Date Received02/05/2025
Decision Date 06/25/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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