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FDA 510(k)

CARBON FIBER BREAST BOARD

K-Number: K974703 · 1998-03-10

ApplicantMedtec, Inc.
Decision Date1998-03-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARBON FIBER BREAST BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K974703. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBON FIBER BREAST BOARD?

CARBON FIBER BREAST BOARD is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Medtec, Inc.. The 510(k) number is K974703.

When did CARBON FIBER BREAST BOARD receive FDA 510(k) clearance?

CARBON FIBER BREAST BOARD received FDA 510(k) clearance on 1998-03-10, under 510(k) number K974703.

Who is the listed applicant for CARBON FIBER BREAST BOARD?

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

What is the FDA product code for CARBON FIBER BREAST BOARD?

The FDA product code for CARBON FIBER BREAST BOARD is IYE.

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Other records listing Medtec, Inc. 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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