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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K042534
Device Name MARINA MEDICAL FINGER PROTECTORS
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 Number878.4460
Classification Product Code
KGO  
Date Received09/17/2004
Decision Date 05/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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