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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K852529
Device Name HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
Applicant
VISITEC CO.
2043 WHITFIELD PARK DR.
SARASOTA,  FL  33580
Applicant Contact THOMAS B GIVENS
Correspondent
VISITEC CO.
2043 WHITFIELD PARK DR.
SARASOTA,  FL  33580
Correspondent Contact THOMAS B GIVENS
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/14/1985
Decision Date 09/24/1985
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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