FDA 510(k) Application Details - K000691

Device Classification Name Arthroscope

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510(K) Number K000691
Device Name Arthroscope
Applicant ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MENLO PARK, CA 94025 US
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Contact JENNIFER BRENNAN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 02/29/2000
Decision Date 05/04/2000
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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