FDA 510(k) Application Details - K993009

Device Classification Name Arthroscope

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510(K) Number K993009
Device Name Arthroscope
Applicant HYDROCISION, INC.
220 BALLARDVALE ST.
WILMINGTON, MA 01887 US
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Contact DEBBIE IAMPIETRO
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/07/1999
Decision Date 10/25/1999
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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