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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Scavenging
510(k) Number K970046
Device Name UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
Applicant
Accutron, Inc.
2020 W. Melinda Ln.
Phoenix,  AZ  85027
Applicant Contact JAMES R MOORE
Correspondent
Accutron, Inc.
2020 W. Melinda Ln.
Phoenix,  AZ  85027
Correspondent Contact JAMES R MOORE
Regulation Number868.5590
Classification Product Code
KHA  
Date Received01/06/1997
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
Predetermined Change
Control Plan Authorized		 No
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