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510(k) K875024

DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP by Dey Laboratories, Inc. — Product Code CCQ

K875024 is an FDA 510(k) premarket notification submitted by Dey Laboratories, Inc. for the device "DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Dey Laboratories, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
December 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

Other clearances by Dey Laboratories, Inc.

  • K972778 — DEY VIAL SODIUM CHLORIDE 3% (October 8, 1997)
  • K910239 — NEBU-SOL METERED DOSE DISPENSER (TM) (May 22, 1991)
  • K880411 — DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE (February 29, 1988)
  • K875011 — DEY-PAK PURIFIED WATER, USP, STERILE (January 22, 1988)
  • K831532 — OCULAR IRRIGATING CANNULA (July 12, 1983)

Other clearances for product code CCQ

  • K972397 — EZ SPRAY (September 23, 1997)
  • K964956 — E-Z SPACER MASK (SMALL) (April 23, 1997)
  • K961894 — MDI TUTOR (August 14, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIR (May 10, 1996)
  • K922033 — SALINE SOLUTION- STERILE (July 21, 1992)
  • K900576 — MODIFIED AEROCHAMBER WITH MASK (May 13, 1991)
  • K900557 — MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (April 10, 1991)
  • K895115 — FRANK INHALER THERMAL S (May 18, 1990)
  • K894215 — EVOLUTION ULTRASONIC (April 16, 1990)

FDA data resources