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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K922143
Device Name AMERICAN BURN SHEET
Applicant
American Silk Sutures, Inc.
82 Sanderson Ave.
Lynn,  MA  01902
Applicant Contact EDWARD M GREENSPAN
Correspondent
American Silk Sutures, Inc.
82 Sanderson Ave.
Lynn,  MA  01902
Correspondent Contact EDWARD M GREENSPAN
Regulation Number880.6060
Classification Product Code
KME  
Date Received05/06/1992
Decision Date 08/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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