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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K053232
Device Name PRECISION BLENDER
Applicant
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Applicant Contact JAMES PARKER
Correspondent
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Correspondent Contact JAMES PARKER
Regulation Number868.5330
Classification Product Code
BZR  
Date Received11/18/2005
Decision Date 01/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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