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510(k) K913164

NON REBREATHING MASK by Specialty Packaging Producs, Inc. — Product Code KGB

K913164 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "NON REBREATHING MASK". The FDA issued a decision of Substantially Equivalent on January 15, 1992. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. 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 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Non-Rebreathing
Device Class
Class I
Regulation Number
868.5570
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)
  • K913216 — TRACH T ADAPTER (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 KGB

  • K970688 — POCKET RESCUE (September 26, 1997)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K941336 — COMBO MASK (September 9, 1994)
  • K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (February 4, 1994)
  • K932347 — COMPACT MASK (January 10, 1994)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION (December 2, 1993)
  • K930336 — PROFAST(R)-DENTURE ADHESIVE CREAM (August 24, 1993)
  • K883766 — MOUTH-TO-MASK VENTILATORY ADJUNCT (October 21, 1988)
  • K790162 — OXYGEN MASK, CONCENTRATION AEROSOL MASK (April 20, 1979)

FDA data resources