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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 K030713
Device Name BAY AREA HYPERSCIENCES
Applicant
BAY AREA HYPERSCIENCES, LLC
18213 SANDY COVE
HOUSTON,  TX  77058
Applicant Contact EDWARD F GOOD
Correspondent
BAY AREA HYPERSCIENCES, LLC
18213 SANDY COVE
HOUSTON,  TX  77058
Correspondent Contact EDWARD F GOOD
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/06/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product Yes
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