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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 K220317
Device Name PuraPly Micronized Wound Matrix (PuraPly MZ)
Applicant
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Applicant Contact Kurdea Lyon
Correspondent
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Correspondent Contact Kurdea Lyon
Classification Product Code
KGN  
Date Received02/03/2022
Decision Date 07/01/2022
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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