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FDA 510(k)

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

K-Number: K960866 · 1996-04-05

ApplicantLake Region Mfg., Inc.
Decision Date1996-04-05
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 1996-04-05 under 510(k) number K960866. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.?

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. is a medical device that received FDA 510(k) clearance on 1996-04-05. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K960866.

When did LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. receive FDA 510(k) clearance?

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. received FDA 510(k) clearance on 1996-04-05, under 510(k) number K960866.

Who is the listed applicant for LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.?

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

What is the FDA product code for LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.?

The FDA product code for LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. is KNY.

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Other records listing Lake Region Mfg., 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.

K092965TRAILRUNNER GUIDEWIRESK082922FREEWAY AND RAILRUNNER GUIDEWIRESK081708TAXI ENDOSCOPIC GUIDEWIREK080144MANDREL GUIDEWIRES OR M-WIRESK073655PEGASUS STEERABLE (PTCA) GUIDEWIREK060454TITAN GUIDEWIRE

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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