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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 K965239
Device Name PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)
Applicant
ACCUTRON, INC.
2020 WEST MELINDA LN.
PHOENIX,  AZ  85027
Applicant Contact JIM MOORE
Correspondent
ACCUTRON, INC.
2020 WEST MELINDA LN.
PHOENIX,  AZ  85027
Correspondent Contact JIM MOORE
Regulation Number868.5430
Classification Product Code
CBN  
Date Received12/31/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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