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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 K953351
Device Name SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS
Applicant
Seatronics Co.
3235 Sunset Ln.
Hatboro,  PA  19040
Applicant Contact MARK GRADY
Correspondent
Seatronics Co.
3235 Sunset Ln.
Hatboro,  PA  19040
Correspondent Contact MARK GRADY
Regulation Number868.1720
Classification Product Code
CCL  
Date Received07/17/1995
Decision Date 10/16/1995
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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