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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, Occlusive
510(k) Number K897156
Device Name HYDRASORB(TM)
Applicant
Avitar, Inc.
250 Tpke. St.
Canton,  MA  02021
Applicant Contact PAUL H PATRONE
Correspondent
Avitar, Inc.
250 Tpke. St.
Canton,  MA  02021
Correspondent Contact PAUL H PATRONE
Regulation Number878.4020
Classification Product Code
NAD  
Date Received12/26/1989
Decision Date 02/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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