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FDA 510(k)

HYDRO-SPLINT A SPONGE-COMPRESS DRESS

K-Number: K843400 · 1984-10-24

ApplicantCompression Splint Products, Inc.
Decision Date1984-10-24
Product CodeFYH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDRO-SPLINT A SPONGE-COMPRESS DRESS is the device name listed in this FDA 510(k) record. The listed applicant is Compression Splint Products, Inc.. It received FDA 510(k) clearance on 1984-10-24 under 510(k) number K843400. The device is classified under product code FYH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRO-SPLINT A SPONGE-COMPRESS DRESS?

HYDRO-SPLINT A SPONGE-COMPRESS DRESS is a medical device that received FDA 510(k) clearance on 1984-10-24. The listed applicant is Compression Splint Products, Inc.. The 510(k) number is K843400.

When did HYDRO-SPLINT A SPONGE-COMPRESS DRESS receive FDA 510(k) clearance?

HYDRO-SPLINT A SPONGE-COMPRESS DRESS received FDA 510(k) clearance on 1984-10-24, under 510(k) number K843400.

Who is the listed applicant for HYDRO-SPLINT A SPONGE-COMPRESS DRESS?

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

What is the FDA product code for HYDRO-SPLINT A SPONGE-COMPRESS DRESS?

The FDA product code for HYDRO-SPLINT A SPONGE-COMPRESS DRESS is FYH.

Related Clinical Trials

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Related Devices (Code: FYH)

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.

K925145TRACE MODEL #'S 840, 841, 842, 845Trace Medical Equipment, Inc.K924984SPECIALIST(R) WALKERJohnson & Johnson Orthopaedics, Inc.K895092KUT-SHIELDKut-Guard, Inc.K852558SPLINTS(ALL TYPE)The Huxley Instrument Corp.K821693J & J DIP WATER ADDITIVEJohnson & Johnson Professionals, Inc.K802522DELTA-LITE CASTING TAPE & SPLINTSJohnson & Johnson Professionals, 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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