FAS SET #4551

Needle, Assisted Reproduction

GYNETICS MEDICAL PRODUCTS NV

The following data is part of a premarket notification filed by Gynetics Medical Products Nv with the FDA for Fas Set #4551.

Pre-market Notification Details

Device IDK013497
510k NumberK013497
Device Name:FAS SET #4551
ClassificationNeedle, Assisted Reproduction
Applicant GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactGrace Holland
CorrespondentGrace Holland
GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeMQE  
CFR Regulation Number884.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-22
Decision Date2001-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
25425017505840 K013497 000
25425017503228 K013497 000
25425017503044 K013497 000

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