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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 K946060
Device Name REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
Applicant
Remington Medical, Inc.
8601 Dunwoody Pl., Suite 510
Atlanta,  GA  30350
Applicant Contact FREDRICK L AYCOCK
Correspondent
Remington Medical, Inc.
8601 Dunwoody Pl., Suite 510
Atlanta,  GA  30350
Correspondent Contact FREDRICK L AYCOCK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/02/1994
Decision Date 04/27/1995
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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