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510(k) K011312

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM by Khrunichev State Research & Production Space Centr — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2001
Date Received
April 30, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

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