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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 K943393
Device Name CIVCO PROBE BOOT/CORD COVER
Applicant
CIVCO Medical Instruments Co., Inc.
Medical Pkwy.
102 Hwy. 1 S.
Kalona,  IA  52247
Applicant Contact J. WILLIAM JONES
Correspondent
CIVCO Medical Instruments Co., Inc.
Medical Pkwy.
102 Hwy. 1 S.
Kalona,  IA  52247
Correspondent Contact J. WILLIAM JONES
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/14/1994
Decision Date 02/02/1995
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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