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510(k) K931038

CONNECTORS AND AIRWAY EXTENSIONS by Med-Plastics Intl., Inc. — Product Code BZA

K931038 is an FDA 510(k) premarket notification submitted by Med-Plastics Intl., Inc. for the device "CONNECTORS AND AIRWAY EXTENSIONS". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Med-Plastics Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
March 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type

Other clearances by Med-Plastics Intl., Inc.

  • K946209 — DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (June 8, 1995)
  • K942568 — ADULT ANESTHESIA BREATHING CIRCUIT (June 10, 1994)
  • K942567 — MASS SPECTROMETRY MONITORING LINES AND CONNECTORS (June 10, 1994)
  • K942570 — MAPLESON D CIRCUIT (June 10, 1994)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K932577 — PEDIATRIC GAS SAMPLING (July 22, 1993)
  • K932575 — ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (July 22, 1993)
  • K932576 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 22, 1993)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources