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FDA 510(k) Application Details - K971342
Device Classification Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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510(K) Number
K971342
Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant
DISK WHISK, INC.
600 SOUTH RANCHO LN., STE. 113
LAS VEGAS, NV 89106 US
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RICK D ROBERTS
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Regulation Number
878.4820
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Classification Product Code
HWE
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More FDA Info for this Product Code
Date Received
04/10/1997
Decision Date
07/08/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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