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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Actuator, Syringe, Injector Type
510(k) Number K880740
Device Name MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
Applicant
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ROBERT L LEAVITT
Correspondent
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ROBERT L LEAVITT
Regulation Number870.1670
Classification Product Code
DQF  
Date Received02/24/1988
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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