FDA 510(k)

SIALOGRAPHY NEEDLE

K-Number: K831666 · 1983-07-12

Decision Date1983-07-12

Product Code

DecisionSubstantially Equivalent

Device Summary

SIALOGRAPHY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Vertex Medical Corp.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831666. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIALOGRAPHY NEEDLE?

SIALOGRAPHY NEEDLE is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Vertex Medical Corp.. The 510(k) number is K831666.

When did SIALOGRAPHY NEEDLE receive FDA 510(k) clearance?

SIALOGRAPHY NEEDLE received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831666.

Who is the listed applicant for SIALOGRAPHY NEEDLE?

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

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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.