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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 K920187
Device Name FLEXIBLE SILICONE GELIHORN
Applicant
Bioteque America, Inc.
51 Rainlily Rd.
Levittown,  PA  19056
Applicant Contact DENIS DORSEY
Correspondent
Bioteque America, Inc.
51 Rainlily Rd.
Levittown,  PA  19056
Correspondent Contact DENIS DORSEY
Regulation Number884.3575
Classification Product Code
HHW  
Date Received01/14/1992
Decision Date 10/23/1992
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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