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FDA 510(k)

BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD

K-Number: K941435 · 1995-04-11

ApplicantNew Eder Corp.
Decision Date1995-04-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD is the device name listed in this FDA 510(k) record. The listed applicant is New Eder Corp.. It received FDA 510(k) clearance on 1995-04-11 under 510(k) number K941435. 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 BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD?

BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is New Eder Corp.. The 510(k) number is K941435.

When did BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD receive FDA 510(k) clearance?

BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD received FDA 510(k) clearance on 1995-04-11, under 510(k) number K941435.

Who is the listed applicant for BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD?

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

What is the FDA product code for BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD?

The FDA product code for BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD is GEI.

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Other records listing New Eder Corp. as applicant

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Official Source

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