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510(k) K953788

UNICOR, INC. GAS SAMPLING LINES & CONNECTORS by Unicor, Inc. — Product Code CAI

K953788 is an FDA 510(k) premarket notification submitted by Unicor, Inc. for the device "UNICOR, INC. GAS SAMPLING LINES & CONNECTORS". The FDA issued a decision of Substantially Equivalent on September 19, 1995. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. 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
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
Review Panel
AN
Submission Type

Other clearances by Unicor, Inc.

  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (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 CAI

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)
  • K945565 — SPIRO-FLEX (January 13, 1995)

FDA data resources