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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K023725
Device Name HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
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 Number878.4750
Classification Product Code
GDW  
Date Received11/06/2002
Decision Date 02/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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