FDA 510(k) Application Details - K002632

Device Classification Name Chamber, Oxygen, Topical, Extremity

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510(K) Number K002632
Device Name Chamber, Oxygen, Topical, Extremity
Applicant ADJUNCTIVE THERAPEUTICS, INC.
10 SCOTCH MIST COURT
POTOMAC, MD 20854 US
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Contact MYRON Z BERNSTEIN
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Regulation Number 878.5650

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Classification Product Code KPJ
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Date Received 08/23/2000
Decision Date 10/25/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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