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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula and trocar, suprapubic, non-disposable
510(k) Number K960400
Device Name DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
Applicant
SNOWDEN-PENCER
5175 SOUTH ROYAL ATLANTA DR.
TUCKER,  GA  30084
Applicant Contact JULIE A STEPHENS
Correspondent
SNOWDEN-PENCER
5175 SOUTH ROYAL ATLANTA DR.
TUCKER,  GA  30084
Correspondent Contact JULIE A STEPHENS
Regulation Number876.5090
Classification Product Code
FBM  
Subsequent Product Codes
GCJ   GEI  
Date Received01/29/1996
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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