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FDA 510(k)

LIMB COVER

K-Number: K780905 · 1978-08-14

ApplicantHydro-Med Products, Inc.
Decision Date1978-08-14
Product CodeIPM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LIMB COVER is the device name listed in this FDA 510(k) record. The listed applicant is Hydro-Med Products, Inc.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K780905. The device is classified under product code IPM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIMB COVER?

LIMB COVER is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Hydro-Med Products, Inc.. The 510(k) number is K780905.

When did LIMB COVER receive FDA 510(k) clearance?

LIMB COVER received FDA 510(k) clearance on 1978-08-14, under 510(k) number K780905.

Who is the listed applicant for LIMB COVER?

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

What is the FDA product code for LIMB COVER?

The FDA product code for LIMB COVER is IPM.

Related Clinical Trials

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Other records listing Hydro-Med Products, 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.

K944198SURGICAL MICROSCOPE DRAPEK940151ULTRASOUND PROBE DRAPEK934630UNIVERSAL VIDEO/LASER ARM DRAPEK940152CAMERA COVER WITH TEAR TIPK923099X-RAY DRAPESK863872TAMPER HAMPER

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Related Devices (Code: IPM)

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.

K872488ELASTO-GEL CAST & SPLINT PADSSouthwest Technologies, Inc.K823399COVER LIMBOrthopedic Systems, Inc.K801627COVER, LIMBThe Owenby Co.K770223HEAVY FOAM HEEL & ELBOW PROTECTORSRobert R. MooreK761114FOAM SLIPPERSFred Sammons, 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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