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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Eye
510(k) Number K850005
Device Name VISOPROTECT OCCULAR SHIELD
Applicant
M.S.G. Health Systems, Inc.
Box 3324 Woodside Rd.
Brunswick,  ME  04011
Applicant Contact MAURICE GHALY
Correspondent
M.S.G. Health Systems, Inc.
Box 3324 Woodside Rd.
Brunswick,  ME  04011
Correspondent Contact MAURICE GHALY
Regulation Number878.4440
Classification Product Code
HMP  
Date Received01/02/1985
Decision Date 03/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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