510(k) K990816

AVCORE SYSTEM by Modular Cutting Systems, Inc. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
March 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type