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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, oxygen, gaseous-phase
510(k) Number K862113
Device Name NO. 100352 GALVANIC OXYGEN SENSOR
Applicant
VASCULAR TECHNOLOGY INCORPORATED
MEDICAL DEVICE CONSULTANTS,INC
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact JAMES R VEALE
Correspondent
VASCULAR TECHNOLOGY INCORPORATED
MEDICAL DEVICE CONSULTANTS,INC
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact JAMES R VEALE
Regulation Number868.1720
Classification Product Code
CCL  
Date Received06/03/1986
Decision Date 06/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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