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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 K983648
Device Name SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
Applicant
Perry Baromedical Services
7555 Garden Rd.
Suite B
Riviera Beach,  FL  33404
Applicant Contact WAYNE C MCCULLOGH
Correspondent
Perry Baromedical Services
7555 Garden Rd.
Suite B
Riviera Beach,  FL  33404
Correspondent Contact WAYNE C MCCULLOGH
Regulation Number868.5470
Classification Product Code
CBF  
Date Received10/16/1998
Decision Date 02/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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