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510(k) K845038

BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT by Ranfac, Corp. — Product Code GDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
December 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code GDF

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  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)