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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 K213573
Device Name PELNAC Wound Matrix
Applicant
Gunze Limited
46 Natsumegaichi, Aono
Ayabe, Kyoto,  JP 623-8513
Applicant Contact Hidenori Nishioka
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R Goldman
Classification Product Code
KGN  
Date Received11/10/2021
Decision Date 02/09/2022
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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