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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 K842990
Device Name STERILE EYE SURGERY KITS
Applicant
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Applicant Contact JAMES P KULLA
Correspondent
Biological & Environmental Control Laboratories
615 Front St.
Toledo,  OH  43605
Correspondent Contact JAMES P KULLA
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received07/30/1984
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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