FDA 510(k) Application Details - K992583

Device Classification Name Arthroscope

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510(K) Number K992583
Device Name Arthroscope
Applicant OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
1100 NEW BRIGHTON BLVD.
MINNEAPOLIS, MN 55413-1660 US
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Contact MICHAEL PONTIUS
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 08/02/1999
Decision Date 10/29/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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