HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU— 510(k) K990913

Substantially Equivalent

Laboratoires Prodimed

FDA 510(k) clearance K990913 for HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU, Substantially Equivalent on 1999-06-08. Applicant: Laboratoires Prodimed. Device class: 2.

Clearance details

Applicant
Laboratoires Prodimed
Product code
Code MQE
Device class
Class 2
Regulation
21 CFR 884.6100
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ringoes, NJ, US
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