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510(k) K833373

BODIA BRONCH-SAF DOUBLE SWIVEL by Sontek Industries, Inc. — Product Code BZA

K833373 is an FDA 510(k) premarket notification submitted by Sontek Industries, Inc. for the device "BODIA BRONCH-SAF DOUBLE SWIVEL". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Sontek Industries, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
September 27, 1983
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 Sontek Industries, Inc.

  • K833372 — BODIA TRACH-SAF DOUBLE SWIVEL (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K813324 — BODAI SWIVEL Y (December 29, 1981)
  • K812720 — BODAI PATIENT COMMUNICATOR (November 5, 1981)
  • K811241 — BODAI SUCTION -SAFE 4 (May 27, 1981)

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