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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 K872612
Device Name SOLOS EYESITE SPONGES
Applicant
Solos Ophthalmology
6191 Atlantic Blvd.
Norcross,  GA  30071
Applicant Contact STEPHEN HOLMES
Correspondent
Solos Ophthalmology
6191 Atlantic Blvd.
Norcross,  GA  30071
Correspondent Contact STEPHEN HOLMES
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received07/06/1987
Decision Date 07/31/1987
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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