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510(k) K880411

DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE by Dey Laboratories, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1988
Date Received
February 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
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)
  • K875011 — DEY-PAK PURIFIED WATER, USP, STERILE (January 22, 1988)
  • K875024 — DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP (January 22, 1988)
  • K831532 — OCULAR IRRIGATING CANNULA (July 12, 1983)

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