FDA 510(k) Application Details - K982266

Device Classification Name Arthroscope

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510(K) Number K982266
Device Name Arthroscope
Applicant HYDROCISION, INC.
220 BALLARDVALE ST.
WILMINGTON, MA 01887 US
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Contact ERIC BANNON
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 06/29/1998
Decision Date 09/25/1998
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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