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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 K842601
Device Name PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
Applicant
Ophthalmic Resources, Inc.
928Eighteenth St. N
St. Petersburg,  FL  33713
Applicant Contact JAMES E VOSE
Correspondent
Ophthalmic Resources, Inc.
928Eighteenth St. N
St. Petersburg,  FL  33713
Correspondent Contact JAMES E VOSE
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received07/05/1984
Decision Date 05/10/1985
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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