FDA 510(k) Application Details - K973195

Device Classification Name Arthroscope

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510(K) Number K973195
Device Name Arthroscope
Applicant Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA, CA 95051-4085 US
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Contact ERIC FINLEY
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 08/26/1997
Decision Date 10/24/1997
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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