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FDA 510(k)

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

K-Number: K001624 · 2001-01-25

ApplicantGebauer Co.
Decision Date2001-01-25
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 is the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Co.. It received FDA 510(k) clearance on 2001-01-25 under 510(k) number K001624. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Gebauer Co.. The 510(k) number is K001624.

When did GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 receive FDA 510(k) clearance?

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 received FDA 510(k) clearance on 2001-01-25, under 510(k) number K001624.

Who is the listed applicant for GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

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 GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04?

The FDA product code for GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 is MLY.

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Other records listing Gebauer Co. 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.

K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03K021726GEBAUER'S INSTANT ICEK981693SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25K002596GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09K991514GEBAUER'S CHLORIDE FINE NOZZE

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Related Devices (Code: MLY)

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.

K261684FreezeSpray TACryosurgery, Inc.K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer CompanyK243654DentalJectVapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLCK203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.K202782num Vapocoolant623 Medical, LLC

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.

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