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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 K882724
Device Name MICROTEK PROBE DRAPE
Applicant
MICROBIO-MEDICS, INC.
POST OFFICE BOX 2487
COLUMBUS,  MS  39704
Applicant Contact KEITH MCGEE
Correspondent
MICROBIO-MEDICS, INC.
POST OFFICE BOX 2487
COLUMBUS,  MS  39704
Correspondent Contact KEITH MCGEE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/01/1988
Decision Date 08/03/1988
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
Recalls CDRH Recalls
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