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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K923972
Device Name OPHTHALMIC FLUID DISTRIBUTION SETS
Applicant
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Applicant Contact DAVID A CLAPP
Correspondent
Visitec Co.
7575 Commerce Ct.
Sarasota,  FL  34243
Correspondent Contact DAVID A CLAPP
Regulation Number880.5440
Classification Product Code
FPK  
Date Received08/07/1992
Decision Date 11/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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