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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 K843788
Device Name CUSTOM BURN DRESSING KIT
Applicant
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Applicant Contact LISA N CURRAN
Correspondent
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Correspondent Contact LISA N CURRAN
Classification Product Code
KGN  
Date Received09/27/1984
Decision Date 11/07/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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