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510(k) K900003

SYSTEM TEN MODEL 100 SURGICAL SYSTEM by Advanced Osseous Technologies — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1990
Date Received
January 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Advanced Osseous Technologies

  • K905451 — SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE (March 5, 1991)

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