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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 K896705
Device Name VISITEC MICRO-SPONGE SPEARS
Applicant
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Applicant Contact LIAQUAT ALLARAKHIA
Correspondent
VISITEC CO.
7575 COMMERCE COURT
SARASOTA,  FL  34243 -3218
Correspondent Contact LIAQUAT ALLARAKHIA
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received11/28/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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