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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K911658
Device Name DIALYSIS TRANDSDUCER PROTECTOR
Applicant
Tico Medical Instruments, Inc.
3600 State Rd. 520
P.O. Box 3823
Cocoa,  FL  32926
Applicant Contact E. J SIMICICH
Correspondent
Tico Medical Instruments, Inc.
3600 State Rd. 520
P.O. Box 3823
Cocoa,  FL  32926
Correspondent Contact E. J SIMICICH
Regulation Number876.5820
Classification Product Code
FIB  
Date Received04/12/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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