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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name curette, suction, endometrial (and accessories)
510(k) Number K021876
Device Name MAS WITH OR WITHOUT SYRINGE
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 Number884.1175
Classification Product Code
HHK  
Date Received06/07/2002
Decision Date 04/08/2003
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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