FDA 510(k) Application Details - K091398

Device Classification Name Arthroscope

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510(K) Number K091398
Device Name Arthroscope
Applicant ORTHOPEDIC SCIENCES, INC
3020 OLD RANCH PARKWAY
SUITE 325
SEAL BEACH, CA 90740 US
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Contact JAMES K BRANNON
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 05/12/2009
Decision Date 08/26/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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