FDA 510(k) Application Details - K041233

Device Classification Name Arthroscope

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510(K) Number K041233
Device Name Arthroscope
Applicant HYDROCISION, INC.
7 TIFFANY TRAIL
HOPKINTON, MA 01748 US
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Contact DEBBIE IMAMPIETRO
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 05/10/2004
Decision Date 07/28/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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