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510(k) K953786

UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS by Unicor, Inc. — Product Code BZA

K953786 is an FDA 510(k) premarket notification submitted by Unicor, Inc. for the device "UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS". The FDA issued a decision of Substantially Equivalent on September 19, 1995. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Unicor, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1995
Date Received
August 14, 1995
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 Unicor, Inc.

  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)

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)
  • 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)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)

FDA data resources