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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 K031463
Device Name MARINA MEDICAL SILICONE PESSARY
Applicant
MARINA MEDICAL INSTRUMENTS, INC.
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
MARINA MEDICAL INSTRUMENTS, INC.
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number884.3575
Classification Product Code
HHW  
Date Received05/08/2003
Decision Date 11/18/2003
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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