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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 K955535
Device Name LOUISVILLE LABS OXYGEN HEAD TENT
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Applicant Contact DAVID PHELPS
Correspondent
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Correspondent Contact DAVID PHELPS
Regulation Number868.5470
Classification Product Code
CBF  
Date Received12/05/1995
Decision Date 07/01/1996
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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