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FDA 510(k)

PREMIUM

K-Number: K930673 · 1993-08-02

ApplicantKinetic Concepts, Inc.
Decision Date1993-08-02
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREMIUM is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1993-08-02 under 510(k) number K930673. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIUM?

PREMIUM is a medical device that received FDA 510(k) clearance on 1993-08-02. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K930673.

When did PREMIUM receive FDA 510(k) clearance?

PREMIUM received FDA 510(k) clearance on 1993-08-02, under 510(k) number K930673.

Who is the listed applicant for PREMIUM?

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

What is the FDA product code for PREMIUM?

The FDA product code for PREMIUM is FNM.

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Other records listing Kinetic Concepts, Inc. as applicant

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K050261V.A.C. GRANUFOAM SILVER PROTECTION DRESSINGK041642V.A.C. GRANUFOAM SILVER DRESSINGK032310MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATSK022011V.A.C. ABDOMINAL DRESSINGK021500VACUUM ASSISTED CLOSUREK021501V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT

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Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

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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