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FDA 510(k)

OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET

K-Number: K072937 · 2007-12-28

ApplicantOlsen Medical
Decision Date2007-12-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Medical. It received FDA 510(k) clearance on 2007-12-28 under 510(k) number K072937. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET?

OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET is a medical device that received FDA 510(k) clearance on 2007-12-28. The listed applicant is Olsen Medical. The 510(k) number is K072937.

When did OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET receive FDA 510(k) clearance?

OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET received FDA 510(k) clearance on 2007-12-28, under 510(k) number K072937.

Who is the listed applicant for OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET?

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

What is the FDA product code for OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET?

The FDA product code for OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET is GEI.

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Other records listing Olsen Medical 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.

K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSK111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPK080187OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPSK042073OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

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Official Source

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