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510(k) K863409

KUNDIN WOUND GAUGE by Jane I. Kundin — Product Code FTY

K863409 is an FDA 510(k) premarket notification submitted by Jane I. Kundin for the device "KUNDIN WOUND GAUGE". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Measuring, Rulers And Calipers
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code FTY

  • K160501 — Noxilizer Surgical Ruler (May 26, 2016)
  • K951064 — DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (May 19, 1995)
  • K934930 — OLYMPIC AUTO-LENGTH (December 29, 1993)
  • K932112 — OLYMPIC INFA-LENGTH (July 22, 1993)
  • K883485 — STRYKER PRESSURE MONITOR SYSTEM (September 13, 1988)
  • K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (February 18, 1988)
  • K874352 — TUMORIMETER (November 23, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K872319 — LN 100 BREAST MARKER (August 11, 1987)
  • K862576 — PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (July 15, 1986)

FDA data resources