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FDA 510(k)

SALIVA SUBSTITUTE

K-Number: K822971 · 1982-11-16

ApplicantRoxane Laboratories, Inc.
Decision Date1982-11-16
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

SALIVA SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Roxane Laboratories, Inc.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K822971. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALIVA SUBSTITUTE?

SALIVA SUBSTITUTE is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Roxane Laboratories, Inc.. The 510(k) number is K822971.

When did SALIVA SUBSTITUTE receive FDA 510(k) clearance?

SALIVA SUBSTITUTE received FDA 510(k) clearance on 1982-11-16, under 510(k) number K822971.

Who is the listed applicant for SALIVA SUBSTITUTE?

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

What is the FDA product code for SALIVA SUBSTITUTE?

The FDA product code for SALIVA SUBSTITUTE is LFD.

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Official Source

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

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