SPERM CAPACITATION MEDIUM

Cap, Cervical

IRVINE SCIENTIFIC

The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Sperm Capacitation Medium.

Pre-market Notification Details

Device IDK861188
510k NumberK861188
Device Name:SPERM CAPACITATION MEDIUM
ClassificationCap, Cervical
Applicant IRVINE SCIENTIFIC CHARLES H. NEWMAN 25283 CABOT ROAD, STE. 207 Laguna Hills,  CA  92653
ContactNewman Assoc.
CorrespondentNewman Assoc.
IRVINE SCIENTIFIC CHARLES H. NEWMAN 25283 CABOT ROAD, STE. 207 Laguna Hills,  CA  92653
Product CodeHDR  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-31
Decision Date1987-01-06

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