DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP

Nebulizer, Medicinal, Non-ventilatory (atomizer)

DEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Dey Laboratories, Inc. with the FDA for Dey-pak And Dey-vial Sodium Chloride Solution, Usp.

Pre-market Notification Details

Device IDK875024
510k NumberK875024
Device Name:DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP
ClassificationNebulizer, Medicinal, Non-ventilatory (atomizer)
Applicant DEY LABORATORIES, INC. 1011 DETROIT AVE. Concord,  CA  94518
ContactRaff, Ph.d.
CorrespondentRaff, Ph.d.
DEY LABORATORIES, INC. 1011 DETROIT AVE. Concord,  CA  94518
Product CodeCCQ  
CFR Regulation Number868.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-04
Decision Date1988-01-22

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