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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 K072255
Device Name MINRAD INC. NASAL SCAVENGING CIRCUIT
Applicant
Minrad, Inc.
50 Cobham Dr.
Orchard Park,  NY  14127 -4121
Applicant Contact JOHN MCNEIMEY
Correspondent
Minrad, Inc.
50 Cobham Dr.
Orchard Park,  NY  14127 -4121
Correspondent Contact JOHN MCNEIMEY
Regulation Number868.5430
Classification Product Code
CBN  
Date Received08/13/2007
Decision Date 10/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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