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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K854571
Device Name DEMAND FLOW VALVE & SONRA W/NASAL MASK
Applicant
Gale E. Dryden
5835 N. Tacoma Ave.
Indianapolis,  IN  46220
Applicant Contact GALE E DRYDEN
Correspondent
Gale E. Dryden
5835 N. Tacoma Ave.
Indianapolis,  IN  46220
Correspondent Contact GALE E DRYDEN
Regulation Number868.5430
Classification Product Code
CBN  
Date Received11/14/1985
Decision Date 02/10/1986
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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