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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 K864034
Device Name OPEN RESERVOIR SCAVENGER
Applicant
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Applicant Contact EDWARD T GRIFFITH
Correspondent
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Correspondent Contact EDWARD T GRIFFITH
Regulation Number868.5430
Classification Product Code
CBN  
Date Received10/15/1986
Decision Date 12/15/1986
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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