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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 K010659
Device Name SEA-LONG MEDICAL TREATMENT HOOD
Applicant
Sea-Long Medical Systems, Inc.
1983 S. Park Rd.
Louisville,  KY  40219
Applicant Contact GERALD COX
Correspondent
Sea-Long Medical Systems, Inc.
1983 S. Park Rd.
Louisville,  KY  40219
Correspondent Contact GERALD COX
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/06/2001
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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