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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 K011565
Device Name INFANT OXYGEN TREATMENT HOOD
Applicant
GULF COAST HYPERBARICS, INC.
4309 GREEN LEAF CIRCLE
PANAMA CITY,  FL  32404
Applicant Contact JAMES W MCCARTHY
Correspondent
GULF COAST HYPERBARICS, INC.
4309 GREEN LEAF CIRCLE
PANAMA CITY,  FL  32404
Correspondent Contact JAMES W MCCARTHY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/21/2001
Decision Date 08/16/2001
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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