FDA 510(k) Application Details - K022028

Device Classification Name Chamber, Oxygen, Topical, Extremity

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510(K) Number K022028
Device Name Chamber, Oxygen, Topical, Extremity
Applicant VASCULAR ONE, INC.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 878.5650

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Classification Product Code KPJ
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Date Received 06/21/2002
Decision Date 12/17/2002
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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