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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name chamber, hyperbaric
510(k) Number K041007
Device Name MILLENIUM, MODELS 2000, 2001 AND 2002
Applicant
HYPERBARIC FOR LIFE LLC
3206 WEST STATE AVE.
PHOENIX,  AZ  85051
Applicant Contact RICK RYDER
Correspondent
HYPERBARIC FOR LIFE LLC
3206 WEST STATE AVE.
PHOENIX,  AZ  85051
Correspondent Contact RICK RYDER
Regulation Number868.5470
Classification Product Code
CBF  
Date Received04/19/2004
Decision Date 11/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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