FDA 510(k) Application Details - K011312

Device Classification Name Chamber, Hyperbaric

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510(K) Number K011312
Device Name Chamber, Hyperbaric
Applicant KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
1811 COPPER RIDGE DR.
SAN ANTONIO, TX 78259-3612 US
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Contact W T WORKMAN
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 04/30/2001
Decision Date 07/18/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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