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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K864111
Device Name STERILE FIELD #605 FENESTRATED STERILE FIELD #606
Applicant
Graham Medical Products
P.O. Box 510, 56 Canal St.
Holyoke,  MA  01041
Applicant Contact W. L BAGGETT
Correspondent
Graham Medical Products
P.O. Box 510, 56 Canal St.
Holyoke,  MA  01041
Correspondent Contact W. L BAGGETT
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/21/1986
Decision Date 10/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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