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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Vaginal
510(k) Number K920633
FOIA Releasable 510(k) K920633
Device Name PESSARY FLEXIBLE SILICONE NICHOLS
Applicant
Bioteque America, Inc.
340 E. Maple Ave.
Suite 102
Langhorne,  PA  19047
Applicant Contact DENNIS DORSEY
Correspondent
Bioteque America, Inc.
340 E. Maple Ave.
Suite 102
Langhorne,  PA  19047
Correspondent Contact DENNIS DORSEY
Regulation Number884.3900
Classification Product Code
KXP  
Date Received02/12/1992
Decision Date 11/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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