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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 K902384
Device Name ABDOMINAL OR C-SECTION DRAPE SHEET
Applicant
MEDICAL PLASTICS, INC.
1050 NORTHFIELD COURT
SUITE 300
ROSWELL,  GA  30076
Applicant Contact JOSEPH S PRINCE
Correspondent
MEDICAL PLASTICS, INC.
1050 NORTHFIELD COURT
SUITE 300
ROSWELL,  GA  30076
Correspondent Contact JOSEPH S PRINCE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/30/1990
Decision Date 08/09/1990
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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