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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Ophthalmic
510(k) Number K850119
Device Name PHARMASEAL EYE PREP TRAY
Applicant
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Applicant Contact LARRY W GETLIN
Correspondent
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Correspondent Contact LARRY W GETLIN
Regulation Number886.4350
Classification Product Code
HNR  
Date Received01/14/1985
Decision Date 05/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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