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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 K994199
Device Name VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
Applicant
Custom Medical Products, Inc.
1 Holiday Inn Dr.
Bldg. E
Asheville,  NC  28806
Applicant Contact STEVE WOODY
Correspondent
Custom Medical Products, Inc.
1 Holiday Inn Dr.
Bldg. E
Asheville,  NC  28806
Correspondent Contact STEVE WOODY
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/13/1999
Decision Date 06/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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