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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K973663
Device Name PALJET-B
Applicant
Golden Gate Bio-Device
22030 Idena Ave.
Castro Valley,  CA  94546
Applicant Contact MARK J HASTINGS
Correspondent
Golden Gate Bio-Device
22030 Idena Ave.
Castro Valley,  CA  94546
Correspondent Contact MARK J HASTINGS
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/25/1997
Decision Date 02/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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