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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, vaginal
510(k) Number K003380
Device Name BIOTEQUE VAGINAL DILATOR
Applicant
BIOTEQUE AMERICA, INC.
340 EAST MAPLE AVE., #204-C
LANGHORNE,  PA  19047
Applicant Contact DENIS DORSEY
Correspondent
BIOTEQUE AMERICA, INC.
340 EAST MAPLE AVE., #204-C
LANGHORNE,  PA  19047
Correspondent Contact DENIS DORSEY
Regulation Number884.3900
Classification Product Code
HDX  
Date Received10/31/2000
Decision Date 01/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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