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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, Hydrophilic
510(k) Number K925841
Device Name HYDRASORB JOYCE SPONGE
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 Number878.4018
Classification Product Code
NAC  
Date Received11/18/1992
Decision Date 05/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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