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FDA 510(k)

SOFTGOOD PRODUCTS AND SPLINTS

K-Number: K803239 · 1981-01-09

ApplicantDanek Medical, Inc.
Decision Date1981-01-09
Product CodeIPX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOFTGOOD PRODUCTS AND SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1981-01-09 under 510(k) number K803239. The device is classified under product code IPX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTGOOD PRODUCTS AND SPLINTS?

SOFTGOOD PRODUCTS AND SPLINTS is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Danek Medical, Inc.. The 510(k) number is K803239.

When did SOFTGOOD PRODUCTS AND SPLINTS receive FDA 510(k) clearance?

SOFTGOOD PRODUCTS AND SPLINTS received FDA 510(k) clearance on 1981-01-09, under 510(k) number K803239.

Who is the listed applicant for SOFTGOOD PRODUCTS AND SPLINTS?

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

What is the FDA product code for SOFTGOOD PRODUCTS AND SPLINTS?

The FDA product code for SOFTGOOD PRODUCTS AND SPLINTS is IPX.

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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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