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510(k) K972860

CURVTEK TSR SYSTEM by Biolectron, Inc. — Product Code HSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1997
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

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