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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name barrier, std, oral sex
510(k) Number K990067
Device Name SHEER GLYDE DAMS
Applicant
LOUISE C. MYERS
14808 N.E. 66TH ST.
REDMOND,  WA  98052 -4712
Applicant Contact LOUISE C MYERS
Correspondent
LOUISE C. MYERS
14808 N.E. 66TH ST.
REDMOND,  WA  98052 -4712
Correspondent Contact LOUISE C MYERS
Regulation Number884.5300
Classification Product Code
MSC  
Date Received01/08/1999
Decision Date 02/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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