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510(k) K913422

OXYGEN TUBING, 81503 by Specialty Packaging Producs, Inc. — Product Code BYX

K913422 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "OXYGEN TUBING, 81503". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1992
Date Received
July 31, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
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)
  • K913216 — TRACH T ADAPTER (January 15, 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 BYX

  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (January 12, 1994)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)
  • K905094 — SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (November 20, 1990)

FDA data resources