Home / 510(k) Clearances / K872319

510(k) K872319

LN 100 BREAST MARKER by Instrumentation Industries, Inc. — Product Code FTY

K872319 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "LN 100 BREAST MARKER". The FDA issued a decision of Substantially Equivalent on August 11, 1987. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1987
Date Received
June 17, 1987
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 Instrumentation Industries, Inc.

  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K162753 — RTC 26-C Inline Aerosol Adapter (February 28, 2017)
  • K113644 — PILOT TUBE REPAIR KIT (January 26, 2012)
  • K102127 — ENDOTRACHEAL TUBE CHANGERS (August 27, 2010)
  • K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (July 22, 2010)
  • K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI AD (December 2, 2009)
  • K081778 — NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (September 12, 2008)
  • K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (September 11, 2008)
  • K991355 — METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (January 27, 2000)
  • K992670 — OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 (September 17, 1999)

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)
  • K863409 — KUNDIN WOUND GAUGE (September 29, 1986)
  • K862576 — PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (July 15, 1986)

FDA data resources