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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Air Handling, Enclosure
510(k) Number K910468
Device Name STERILE DISPOSABLE DRAPE(S)
Applicant
E.M. Adams
121 W. St.
Medfield,  MA  02052
Applicant Contact RICHARD K DONAHUE
Correspondent
E.M. Adams
121 W. St.
Medfield,  MA  02052
Correspondent Contact RICHARD K DONAHUE
Regulation Number878.5070
Classification Product Code
FZI  
Date Received02/04/1991
Decision Date 03/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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