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FDA 510(k)

MEDI-TRACE DEFIB PADS

K-Number: K955597 · 1996-07-09

ApplicantGraphic Controls Corp.
Decision Date1996-07-09
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE DEFIB PADS is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1996-07-09 under 510(k) number K955597. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TRACE DEFIB PADS?

MEDI-TRACE DEFIB PADS is a medical device that received FDA 510(k) clearance on 1996-07-09. The listed applicant is Graphic Controls Corp.. The 510(k) number is K955597.

When did MEDI-TRACE DEFIB PADS receive FDA 510(k) clearance?

MEDI-TRACE DEFIB PADS received FDA 510(k) clearance on 1996-07-09, under 510(k) number K955597.

Who is the listed applicant for MEDI-TRACE DEFIB PADS?

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

What is the FDA product code for MEDI-TRACE DEFIB PADS?

The FDA product code for MEDI-TRACE DEFIB PADS is GYB.

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Other records listing Graphic Controls Corp. as applicant

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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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