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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 K945656
Device Name THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
Applicant
Micro-Medical Devices, Inc.
317 Paragon Way
Castle Pines Village,  CO  80104
Applicant Contact EDWIN L ADAIR
Correspondent
Micro-Medical Devices, Inc.
317 Paragon Way
Castle Pines Village,  CO  80104
Correspondent Contact EDWIN L ADAIR
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/17/1994
Decision Date 03/28/1995
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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