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FDA 510(k)

LUBE JELLY SURINGE

K-Number: K121390 · 2012-08-10

ApplicantNurse Assist, Inc.
Decision Date2012-08-10
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUBE JELLY SURINGE is the device name listed in this FDA 510(k) record. The listed applicant is Nurse Assist, Inc.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K121390. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUBE JELLY SURINGE?

LUBE JELLY SURINGE is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Nurse Assist, Inc.. The 510(k) number is K121390.

When did LUBE JELLY SURINGE receive FDA 510(k) clearance?

LUBE JELLY SURINGE received FDA 510(k) clearance on 2012-08-10, under 510(k) number K121390.

Who is the listed applicant for LUBE JELLY SURINGE?

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

What is the FDA product code for LUBE JELLY SURINGE?

The FDA product code for LUBE JELLY SURINGE is KMJ.

Related Clinical Trials

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.

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Other records listing Nurse Assist, 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.

K083042WOUND FLUSH, STERILE WATER & NORMAL SALINE

Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal CorporationK092488DYNAREX STERILE LUBRICATING JELLYDynarex Corporation

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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