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510(k) K913216

TRACH T ADAPTER by Specialty Packaging Producs, Inc. — Product Code BZA

K913216 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "TRACH T ADAPTER". The FDA issued a decision of Substantially Equivalent on January 15, 1992. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1992
Date Received
July 19, 1991
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 Specialty Packaging Producs, Inc.

  • K922492 — SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER (August 24, 1992)
  • K913163 — NON REBREATHING VALVE (February 3, 1992)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K913383 — OXYGEN MASKS 81420, 81421, 81471 & 81461 (October 18, 1991)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K913220 — AEROSOL MASKS, 81426, 81476, 81490 & 81492 (October 10, 1991)
  • K913275 — VENTURI OXYGEN MASK (October 10, 1991)
  • K913455 — OXYGEN MASKS 82400 & 82405 (October 2, 1991)
  • K910896 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT (May 8, 1991)

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