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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K863981
Device Name STERILIZATION WRAPS #620,624,648,640,636,630,612
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 Number880.6850
Classification Product Code
FRG  
Date Received10/14/1986
Decision Date 11/25/1986
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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