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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K973621
Device Name PRE-VIEW CHOLANGIOGRAPHY CLAMP
Applicant
Nashville Surgical Instruments
322 Northcrest Dr.
Springfield,  TN  37172
Applicant Contact S.S. KUMAR
Correspondent
Nashville Surgical Instruments
322 Northcrest Dr.
Springfield,  TN  37172
Correspondent Contact S.S. KUMAR
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received09/23/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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