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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 K905168
Device Name HYPERLITE
Applicant
S.O.S. LTD.
P.O. BOX 328
LONDON NW73JS, ENGLAND,  GB
Applicant Contact SELBY
Correspondent
S.O.S. LTD.
P.O. BOX 328
LONDON NW73JS, ENGLAND,  GB
Correspondent Contact SELBY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received11/16/1990
Decision Date 07/22/1991
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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