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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart-Valve Movement, Fetal, Ultrasonic
510(k) Number K920985
Device Name SNOWDEN-PENCER IRRIGATION PUMP
Applicant
SNOWDEN-PENCER
2058 KILMAN DR.
TUCKER,  GA  30084
Applicant Contact BLACK, III
Correspondent
SNOWDEN-PENCER
2058 KILMAN DR.
TUCKER,  GA  30084
Correspondent Contact BLACK, III
Regulation Number884.2660
Classification Product Code
HEI  
Date Received03/02/1992
Decision Date 06/09/1992
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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