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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K905017
Device Name LAB-SITE
Applicant
Telos Medical Corp.
2044 W. 11th St.
Keene,  CA  91786
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Telos Medical Corp.
2044 W. 11th St.
Keene,  CA  91786
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/07/1990
Decision Date 01/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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