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510(k) K913455

OXYGEN MASKS 82400 & 82405 by Specialty Packaging Producs, Inc. — Product Code BYG

K913455 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "OXYGEN MASKS 82400 & 82405". The FDA issued a decision of Substantially Equivalent on October 2, 1991. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1991
Date Received
August 2, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
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)
  • K913216 — TRACH T ADAPTER (January 15, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K913383 — OXYGEN MASKS 81420, 81421, 81471 & 81461 (October 18, 1991)
  • K913275 — VENTURI OXYGEN MASK (October 10, 1991)
  • K913220 — AEROSOL MASKS, 81426, 81476, 81490 & 81492 (October 10, 1991)
  • K910896 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT (May 8, 1991)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)

FDA data resources