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FDA 510(k)

MED-TEC BREAST SUPPORT SYSTEM

K-Number: K942282 · 1994-07-18

ApplicantMedtec, Inc.
Decision Date1994-07-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MED-TEC BREAST SUPPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K942282. 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 MED-TEC BREAST SUPPORT SYSTEM?

MED-TEC BREAST SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Medtec, Inc.. The 510(k) number is K942282.

When did MED-TEC BREAST SUPPORT SYSTEM receive FDA 510(k) clearance?

MED-TEC BREAST SUPPORT SYSTEM received FDA 510(k) clearance on 1994-07-18, under 510(k) number K942282.

Who is the listed applicant for MED-TEC BREAST SUPPORT SYSTEM?

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 MED-TEC BREAST SUPPORT SYSTEM?

The FDA product code for MED-TEC BREAST SUPPORT SYSTEM is IYE.

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Other records listing Medtec, 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.

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Related Devices (Code: IYE)

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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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