FDA 510(k)

SALINE, ISOTONIC BUFFERED, AZIDE-FREE

K-Number: K760129 · 1976-07-20

Decision Date1976-07-20

Product CodeGIF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SALINE, ISOTONIC BUFFERED, AZIDE-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760129. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALINE, ISOTONIC BUFFERED, AZIDE-FREE?

SALINE, ISOTONIC BUFFERED, AZIDE-FREE is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is Harleco. The 510(k) number is K760129.

When did SALINE, ISOTONIC BUFFERED, AZIDE-FREE receive FDA 510(k) clearance?

SALINE, ISOTONIC BUFFERED, AZIDE-FREE received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760129.

Who is the listed applicant for SALINE, ISOTONIC BUFFERED, AZIDE-FREE?

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

What is the FDA product code for SALINE, ISOTONIC BUFFERED, AZIDE-FREE?

The FDA product code for SALINE, ISOTONIC BUFFERED, AZIDE-FREE is GIF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.