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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K850050
Device Name PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
Applicant
PROFESSIONAL MEDICAL SERVICES
P.O. BOX 250
700 WEST 200 NORTH
NORTH SALT LAKE,  UT  84054
Applicant Contact JAMES E WILLIAMS
Correspondent
PROFESSIONAL MEDICAL SERVICES
P.O. BOX 250
700 WEST 200 NORTH
NORTH SALT LAKE,  UT  84054
Correspondent Contact JAMES E WILLIAMS
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received01/08/1985
Decision Date 04/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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