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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, Antimicrobial
510(k) Number K922059
Device Name DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
Applicant
Graham Medical Products
P.O. Box 510, 56 Canal St.
Holyoke,  MA  01041
Applicant Contact PHYLLIS PIET-HUGHES
Correspondent
Graham Medical Products
P.O. Box 510, 56 Canal St.
Holyoke,  MA  01041
Correspondent Contact PHYLLIS PIET-HUGHES
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/28/1992
Decision Date 03/03/1993
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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