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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, laparoscopic
510(k) Number K913835
Device Name SNOWDEN-PENCER INSUFFLATOR TUBING SET
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 Number884.1730
Classification Product Code
HIF  
Date Received08/26/1991
Decision Date 11/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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