FDA 510(k) Application Details - K853763

Device Classification Name

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510(K) Number K853763
Device Name TENDON STRIPPER
Applicant ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD, CA US
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Contact ROBERT R MOORE
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Regulation Number

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Classification Product Code ZZZ
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Date Received 09/09/1985
Decision Date 10/07/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee -
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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