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510(k) K854892

RULER by Euro-Med Intl. — Product Code FTY

K854892 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "RULER". The FDA issued a decision of Substantially Equivalent on December 24, 1985. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Euro-Med Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1985
Date Received
December 6, 1985
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 by Euro-Med Intl.

  • K883884 — PROSTATIC CORE-CUT NEEDLE (December 5, 1988)
  • K882404 — KEVOR-CURETTE (July 8, 1988)
  • K854901 — PACIFIC GRASPER (May 2, 1986)
  • K854896 — HOOK SCISSOR (May 2, 1986)
  • K854894 — SPOON (May 2, 1986)
  • K854890 — HOOK PROBE (May 2, 1986)
  • K854895 — BASKET FORCEP (May 2, 1986)
  • K854891 — KNIFE (May 2, 1986)
  • K854897 — MAX-I-GRASP (May 2, 1986)
  • K854898 — ATLANTIC GRASPER (May 2, 1986)

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)
  • K863409 — KUNDIN WOUND GAUGE (September 29, 1986)

FDA data resources