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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 K850099
Device Name VISOPROTECT: OCCULAR SHIELD
Applicant
Rockway Enterprises, Inc.
P.O. Box 8
St George,  ME  04857
Applicant Contact ONAT
Correspondent
Rockway Enterprises, Inc.
P.O. Box 8
St George,  ME  04857
Correspondent Contact ONAT
Regulation Number878.4440
Classification Product Code
HMP  
Date Received01/11/1985
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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