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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 K913979
Device Name ENDO I/A Y 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 Received09/06/1991
Decision Date 11/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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