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FDA 510(k)

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM

K-Number: K911911 · 1992-03-20

ApplicantMedical Design & Manufacturing Corp.
Decision Date1992-03-20
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design & Manufacturing Corp.. It received FDA 510(k) clearance on 1992-03-20 under 510(k) number K911911. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM?

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-20. The listed applicant is Medical Design & Manufacturing Corp.. The 510(k) number is K911911.

When did MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM receive FDA 510(k) clearance?

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM received FDA 510(k) clearance on 1992-03-20, under 510(k) number K911911.

Who is the listed applicant for MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM?

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

What is the FDA product code for MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM?

The FDA product code for MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM is HCC.

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Other records listing Medical Design & Manufacturing Corp. 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.

K914384MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODEK911366PROTECTOR DISPOSABLE TENS AND NMES ELECTRODEK902822MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICEK895604SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODESK880492INTERCEPT T.E.N.S. DEVICEK834138HYPO SUTURE

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Related Devices (Code: HCC)

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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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