GENT-L-SPEC DISPOS. VAGINAL SPECULUM

Speculum, Vaginal, Nonmetal

GENEVA LABORATORIES, INC.

The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Gent-l-spec Dispos. Vaginal Speculum.

Pre-market Notification Details

Device IDK830725
510k NumberK830725
Device Name:GENT-L-SPEC DISPOS. VAGINAL SPECULUM
ClassificationSpeculum, Vaginal, Nonmetal
Applicant GENEVA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHIB  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-08
Decision Date1983-04-27

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