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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K110608
Device Name SEVOFLURANE VAPORIZER ADAPTOR
Applicant
Piramal Critcal Care, Inc (Formerly Minrad, Inc)
50 Cobham Dr.
Orchard Park,  NY  14127
Applicant Contact JAMIE KELLER
Correspondent
Piramal Critcal Care, Inc (Formerly Minrad, Inc)
50 Cobham Dr.
Orchard Park,  NY  14127
Correspondent Contact JAMIE KELLER
Regulation Number868.5880
Classification Product Code
CAD  
Date Received03/03/2011
Decision Date 07/20/2011
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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