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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K013289
FOIA Releasable 510(k) K013289
Device Name BIOTEQUE VAGINAL PESSARIES
Applicant
Bioteque America, Inc.
340 E. Maple Ave., #204-C
Langhorne,  PA  19047
Applicant Contact DENIS DORSEY
Correspondent
Bioteque America, Inc.
340 E. Maple Ave., #204-C
Langhorne,  PA  19047
Correspondent Contact DENIS DORSEY
Regulation Number884.3575
Classification Product Code
HHW  
Date Received10/02/2001
Decision Date 12/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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