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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K852374
Device Name OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18
Applicant
The Timeter Group
2501 Oregon Pike
Lancaster,  PA  17601
Applicant Contact TERRY L LANDIS
Correspondent
The Timeter Group
2501 Oregon Pike
Lancaster,  PA  17601
Correspondent Contact TERRY L LANDIS
Regulation Number868.2700
Classification Product Code
CAN  
Date Received06/04/1985
Decision Date 07/12/1985
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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