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FDA 510(k)

DEY VIAL SODIUM CHLORIDE 3%

K-Number: K972778 · 1997-10-08

ApplicantDey Laboratories, Inc.
Decision Date1997-10-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEY VIAL SODIUM CHLORIDE 3% is the device name listed in this FDA 510(k) record. The listed applicant is Dey Laboratories, Inc.. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K972778. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEY VIAL SODIUM CHLORIDE 3%?

DEY VIAL SODIUM CHLORIDE 3% is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Dey Laboratories, Inc.. The 510(k) number is K972778.

When did DEY VIAL SODIUM CHLORIDE 3% receive FDA 510(k) clearance?

DEY VIAL SODIUM CHLORIDE 3% received FDA 510(k) clearance on 1997-10-08, under 510(k) number K972778.

Who is the listed applicant for DEY VIAL SODIUM CHLORIDE 3%?

The FDA 510(k) record lists Dey Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEY VIAL SODIUM CHLORIDE 3%?

The FDA product code for DEY VIAL SODIUM CHLORIDE 3% is CAF.

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Other records listing Dey Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910239NEBU-SOL METERED DOSE DISPENSER (TM)K880411DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILEK875011DEY-PAK PURIFIED WATER, USP, STERILEK875024DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USPK831532OCULAR IRRIGATING CANNULA

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Official Source

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