FDA 510(k) Application Details - K032358

Device Classification Name Arthroscope

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510(K) Number K032358
Device Name Arthroscope
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact JONANTHAN S KAHN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 07/30/2003
Decision Date 12/17/2003
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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