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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 K002384
Device Name M-XX OXYGEN SENSORS
Applicant
INTERNATIONAL BUSINESS STRATEGIES
1667A MARSH HABOR LN.
MOUNT PLEASANT,  SC  29464
Applicant Contact WILLIAM ROETTGER
Correspondent
INTERNATIONAL BUSINESS STRATEGIES
1667A MARSH HABOR LN.
MOUNT PLEASANT,  SC  29464
Correspondent Contact WILLIAM ROETTGER
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/04/2000
Decision Date 12/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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