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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 K885232
Device Name FLUID DRAINAGE WICK
Applicant
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Applicant Contact LIAQUAT ALLARAKHIA
Correspondent
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Correspondent Contact LIAQUAT ALLARAKHIA
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received12/20/1988
Decision Date 02/08/1989
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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