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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 K771548
Device Name SILASTIC BRAND INTRAVAGINAL TARSETTE
Applicant
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.3575
Classification Product Code
HHW  
Date Received08/12/1977
Decision Date 11/07/1977
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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