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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Eye
510(k) Number K800404
Device Name MEDSPEC OPERATIVE OPTHALMIC KIT
Applicant
Medi-Spec
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medi-Spec
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4440
Classification Product Code
HMP  
Date Received02/26/1980
Decision Date 04/24/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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