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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, assisted reproduction
510(k) Number K990913
Device Name HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
Applicant
LABORATOIRES PRODIMED
23 WELISEWITZ RD.
RINGOES,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
LABORATOIRES PRODIMED
23 WELISEWITZ RD.
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number884.6100
Classification Product Code
MQE  
Date Received03/18/1999
Decision Date 06/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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