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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K222025
Device Name G4Derm / G4Derm Plus Synthetic Wound Matrix
Applicant
Gel4med, Inc.
1660 Soldiers Field Rd. Suite 7 #1063
Brighton,  MA  02135
Applicant Contact Ana Tellechea
Correspondent
Gel4med, Inc.
1660 Soldiers Field Rd. Suite 7 #1063
Brighton,  MA  02135
Correspondent Contact Ana Tellechea
Classification Product Code
FRO  
Date Received07/11/2022
Decision Date 10/11/2023
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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