FLEXIBLE SILICONE GELIHORN

Pessary, Vaginal

BIOTEQUE AMERICA, INC.

The following data is part of a premarket notification filed by Bioteque America, Inc. with the FDA for Flexible Silicone Gelihorn.

Pre-market Notification Details

Device IDK920187
510k NumberK920187
Device Name:FLEXIBLE SILICONE GELIHORN
ClassificationPessary, Vaginal
Applicant BIOTEQUE AMERICA, INC. 51 RAINLILY RD. Levittown,  PA  19056
ContactDenis Dorsey
CorrespondentDenis Dorsey
BIOTEQUE AMERICA, INC. 51 RAINLILY RD. Levittown,  PA  19056
Product CodeHHW  
CFR Regulation Number884.3575 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-14
Decision Date1992-10-23

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