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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K051700
Device Name OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR
Applicant
Medchannel, LLC
55 Worcester St. #3
Boston,  MA  02118
Applicant Contact FREDERICK TOBIA
Correspondent
Medchannel, LLC
55 Worcester St. #3
Boston,  MA  02118
Correspondent Contact FREDERICK TOBIA
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
FEB  
Date Received06/24/2005
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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