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FDA 510(k)

NU-PREP GEL

K-Number: K933798 · 1994-04-22

ApplicantCadwell Laboratories, Inc.
Decision Date1994-04-22
Product CodeGXB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NU-PREP GEL is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1994-04-22 under 510(k) number K933798. The device is classified under product code GXB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NU-PREP GEL?

NU-PREP GEL is a medical device that received FDA 510(k) clearance on 1994-04-22. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K933798.

When did NU-PREP GEL receive FDA 510(k) clearance?

NU-PREP GEL received FDA 510(k) clearance on 1994-04-22, under 510(k) number K933798.

Who is the listed applicant for NU-PREP GEL?

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

What is the FDA product code for NU-PREP GEL?

The FDA product code for NU-PREP GEL is GXB.

Other records listing Cadwell Laboratories, Inc. 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.

K061706CADWELL EASYNET OXIMETER MODULEK061705CADWELL EASYNET NASAL PRESSURE MODULEK042350TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATORK040986CADWELL LIMB MOVEMENT MODULEK040932EASYNET BODY POSITION MODULEK971214KILOWIN

View all 46 devices →

Related Devices (Code: GXB)

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.

K871571NEUROTIPS(TM)Ulster Scientific, Inc.K801907ALGESIOMETERRowan Products, Inc.K772406AESTHESIOMETERFred Sammons, Inc.K771847TEMP-TESTERJablecki, Charles, Dr.K761133AESTHESIOMETERFred Sammons, Inc.

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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