MEDWORKS INSEMINATION CATHETER— 510(k) K982628

Substantially Equivalent

Medworks Corp.

FDA 510(k) clearance K982628 for MEDWORKS INSEMINATION CATHETER, Substantially Equivalent on 1998-08-21. Applicant: Medworks Corp.. Device class: 2.

Clearance details

Applicant: Medworks Corp.
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1998-07-28
Decision date: 1998-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pawtucket, RI, US

Download summary PDF View on FDA.gov ↗

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