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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 K875183
Device Name LC OXYGEN ANALYZER
Applicant
Ametek/Thermox Instruments Division
150 Freeport Rd.
Pittsburgh,  PA  15238
Applicant Contact RICHARD W WANEK
Correspondent
Ametek/Thermox Instruments Division
150 Freeport Rd.
Pittsburgh,  PA  15238
Correspondent Contact RICHARD W WANEK
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/22/1987
Decision Date 03/29/1988
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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