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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 K920747
Device Name PESSARY FLEXIBLE SILICONE DONUT RING
Applicant
Bioteque America, Inc.
340 E. Maple Ave.
Suite 102
Langhorne,  PA  19047
Applicant Contact DENIS DORSEY
Correspondent
Bioteque America, Inc.
340 E. Maple Ave.
Suite 102
Langhorne,  PA  19047
Correspondent Contact DENIS DORSEY
Regulation Number884.3575
Classification Product Code
HHW  
Date Received02/19/1992
Decision Date 08/29/1994
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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