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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K930667
Device Name REUSABLE LAPAROSCOPIC INSTRUMENTS
Applicant
SNOWDEN-PENCER
2058 KILMAN DR.
TUCKER,  GA  30084
Applicant Contact NORMAN M BLACK
Correspondent
SNOWDEN-PENCER
2058 KILMAN DR.
TUCKER,  GA  30084
Correspondent Contact NORMAN M BLACK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/09/1993
Decision Date 05/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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