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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
510(k) Number K961906
Device Name UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
Applicant
Spectrum Medsystems Corp.
2166 Michelson Dr.
Irvine,  CA  92715 -1304
Applicant Contact THOMAS L HURSMAN
Correspondent
Spectrum Medsystems Corp.
2166 Michelson Dr.
Irvine,  CA  92715 -1304
Correspondent Contact THOMAS L HURSMAN
Regulation Number876.5250
Classification Product Code
EYZ  
Date Received05/16/1996
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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