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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K912415
Device Name MEDICAL SAFETY CABLE AND LEAD SYSTEM
Applicant
Medtronic Vascular
60 Newark St.
Haverhill,  MA  01830
Applicant Contact JANICE M PEVIDE
Correspondent
Medtronic Vascular
60 Newark St.
Haverhill,  MA  01830
Correspondent Contact JANICE M PEVIDE
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/31/1991
Decision Date 08/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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