FDA 510(k)

SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25

K-Number: K981693 · 2001-08-06

Decision Date2001-08-06

Product CodeLFD

DecisionSubstantially Equivalent

Device Summary

SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 is the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Co.. It received FDA 510(k) clearance on 2001-08-06 under 510(k) number K981693. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25?

SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 is a medical device that received FDA 510(k) clearance on 2001-08-06. The listed applicant is Gebauer Co.. The 510(k) number is K981693.

When did SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 receive FDA 510(k) clearance?

SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 received FDA 510(k) clearance on 2001-08-06, under 510(k) number K981693.

Who is the listed applicant for SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25?

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

What is the FDA product code for SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25?

The FDA product code for SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 is LFD.

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Other records listing Gebauer Co. as applicant

K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 K021726GEBAUER'S INSTANT ICE K002596GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 K001624GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 K991514GEBAUER'S CHLORIDE FINE NOZZE

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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.