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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Cleaning / Lubricating, Artificial Eye
510(k) Number K893829
Device Name POWERED EYE WASH
Applicant
Sacks Model Makers
509 Skyline Lks. Dr.
Ringwood,  NJ  07456
Applicant Contact HERMAN SACKS
Correspondent
Sacks Model Makers
509 Skyline Lks. Dr.
Ringwood,  NJ  07456
Correspondent Contact HERMAN SACKS
Classification Product Code
MSI  
Date Received05/24/1989
Decision Date 11/14/1989
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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