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FDA 510(k) Application Details - K993010
Device Classification Name
Chamber, Hyperbaric
More FDA Info for this Device
510(K) Number
K993010
Device Name
Chamber, Hyperbaric
Applicant
ENVIRONMENTAL TECTONICS CORP.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
HOWARD M HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number
868.5470
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Classification Product Code
CBF
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More FDA Info for this Product Code
Date Received
09/07/1999
Decision Date
05/30/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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