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510(k) K812713

DRAWER TEST by Medmetric Corp. — Product Code FTY

K812713 is an FDA 510(k) premarket notification submitted by Medmetric Corp. for the device "DRAWER TEST". The FDA issued a decision of Substantially Equivalent on November 5, 1981. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Medmetric Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1981
Date Received
September 25, 1981
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 Medmetric Corp.

  • K943197 — KT1000/S KNEE LIGAMENT ARTHROMETER (March 2, 1995)
  • K942059 — KT2000 KNEE LIGAMENT ARTHROMETER (September 20, 1994)
  • K904823 — FLEXERCYCLE (January 30, 1991)
  • K904898 — TORQUE FRAME QTF1000 (November 28, 1990)
  • K854254 — TENSION-ISOMETER (November 15, 1985)
  • K812806 — KT-1000 DEVICE (November 10, 1981)
  • K801572 — SURG-ASSIST (August 4, 1980)

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