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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K010747
Device Name OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
Applicant
Western Ent.
875 Bassett Rd.
Westlake,  OH  44145
Applicant Contact BYRON CRAMPTON
Correspondent
Western Ent.
875 Bassett Rd.
Westlake,  OH  44145
Correspondent Contact BYRON CRAMPTON
Regulation Number868.5905
Classification Product Code
NFB  
Date Received03/13/2001
Decision Date 05/16/2001
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
Recalls CDRH Recalls
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