FDA 510(k) Application Details - K961725

Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment

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510(K) Number K961725
Device Name Instrument, Surgical, Sonic And Accessory/Attachment
Applicant C.L. MCINTOSH & ASSOC., INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact ROBERT L SHERIDAN
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Regulation Number 888.4580

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Classification Product Code JDX
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Date Received 05/03/1996
Decision Date 08/01/1996
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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