BIOTEQUE VAGINAL DILATOR

Dilator, Vaginal

BIOTEQUE AMERICA, INC.

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

Pre-market Notification Details

Device IDK003380
510k NumberK003380
Device Name:BIOTEQUE VAGINAL DILATOR
ClassificationDilator, Vaginal
Applicant BIOTEQUE AMERICA, INC. 340 EAST MAPLE AVE., #204-C Langhorne,  PA  19047
ContactDenis Dorsey
CorrespondentDenis Dorsey
BIOTEQUE AMERICA, INC. 340 EAST MAPLE AVE., #204-C Langhorne,  PA  19047
Product CodeHDX  
CFR Regulation Number884.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-31
Decision Date2001-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30649111062630 K003380 000
30649111062364 K003380 000
30649111061916 K003380 000
10381780169932 K003380 000
10381780169925 K003380 000
10381780169918 K003380 000

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