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510(k) K874665

SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY by Precision Dynamics Corp. — Product Code LRP

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
January 20, 1988
Date Received
November 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K863164 — AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (August 27, 1986)
  • K851364 — FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP (April 22, 1985)

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