THECURVE, ITEM 507

Cannula, Intrauterine Insemination

SELECT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Select Medical Systems, Inc. with the FDA for Thecurve, Item 507.

Pre-market Notification Details

Device IDK012935
510k NumberK012935
Device Name:THECURVE, ITEM 507
ClassificationCannula, Intrauterine Insemination
Applicant SELECT MEDICAL SYSTEMS, INC. P.O. BOX 966 Williston,  VT  05495 -0966
ContactMonique Girard
CorrespondentMonique Girard
SELECT MEDICAL SYSTEMS, INC. P.O. BOX 966 Williston,  VT  05495 -0966
Product CodeMFD  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-31
Decision Date2001-10-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60888937003644 K012935 000
20888937003608 K012935 000

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