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FDA 510(k)

OMNI-JUG

K-Number: K952200 · 1995-06-29

ApplicantWaterstone Medical, Inc.
Decision Date1995-06-29
Product CodeKDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNI-JUG is the device name listed in this FDA 510(k) record. The listed applicant is Waterstone Medical, Inc.. It received FDA 510(k) clearance on 1995-06-29 under 510(k) number K952200. The device is classified under product code KDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-JUG?

OMNI-JUG is a medical device that received FDA 510(k) clearance on 1995-06-29. The listed applicant is Waterstone Medical, Inc.. The 510(k) number is K952200.

When did OMNI-JUG receive FDA 510(k) clearance?

OMNI-JUG received FDA 510(k) clearance on 1995-06-29, under 510(k) number K952200.

Who is the listed applicant for OMNI-JUG?

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

What is the FDA product code for OMNI-JUG?

The FDA product code for OMNI-JUG is KDG.

Related Devices (Code: KDG)

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.

K952678STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KITAvail-Southwest DivisionK894785SURGICAL CHISEL/OSTEOTOMEFdt Precision Machine Co., Inc.K891471SIL-MED WASTE FLUID DUMP BAGSil-Med Corp.K872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSPorex MedicalK872092OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5Military Engineering, Inc.K842824CHERMEL BONE CHISELSCher Mel Corp.

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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