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510(k) K812744

LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER by Progress Mankind Technology — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1981
Date Received
September 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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  • K845036 — TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 (June 26, 1985)
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  • K831329 — PMT VAXIOM STEREOTACTIC SYS #FX001 (June 15, 1983)
  • K830530 — TEMP TRACE (April 6, 1983)
  • K810627 — MODEL 1301 BIOTAC (TM) (April 2, 1981)

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