MEDWORKS INSEMINATION CATHETER

Cannula, Intrauterine Insemination

MEDWORKS CORP.

The following data is part of a premarket notification filed by Medworks Corp. with the FDA for Medworks Insemination Catheter.

Pre-market Notification Details

Device IDK982628
510k NumberK982628
Device Name:MEDWORKS INSEMINATION CATHETER
ClassificationCannula, Intrauterine Insemination
Applicant MEDWORKS CORP. 50 BREWSTER ST. Pawtucket,  RI  02860
ContactPamela Papineau
CorrespondentPamela Papineau
MEDWORKS CORP. 50 BREWSTER ST. Pawtucket,  RI  02860
Product CodeMFD  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-28
Decision Date1998-08-21
Summary:summary

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