FDA 510(k) Application Details - K981636

Device Classification Name Arthroscope

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510(K) Number K981636
Device Name Arthroscope
Applicant LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
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Contact CAROL A WEIDEMAN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 05/08/1998
Decision Date 08/20/1998
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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