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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Patient, Ophthalmic
510(k) Number K872620
Device Name SOLOS EYESITE DRAPES
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 Number878.4370
Classification Product Code
HMT  
Date Received07/06/1987
Decision Date 07/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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