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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 K232758
Device Name Comatryx OTC
Applicant
Strukmyer Medical, LLC
1801 Big Town Blvd.
Suite 100
Mesquite,  TX  75149
Applicant Contact Christian Quinto
Correspondent
Richard Hamer Associates, LLC
705 Spring Lakes Blvd.
Bradenton,  FL  34210
Correspondent Contact Richard Hamer
Classification Product Code
KGN  
Date Received09/08/2023
Decision Date 12/01/2023
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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