FDA 510(k)

FOAM WEDGES

K-Number: K821647 · 1982-06-11

Decision Date1982-06-11

Product Code

DecisionSubstantially Equivalent

Device Summary

FOAM WEDGES is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1982-06-11 under 510(k) number K821647. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOAM WEDGES?

FOAM WEDGES is a medical device that received FDA 510(k) clearance on 1982-06-11. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K821647.

When did FOAM WEDGES receive FDA 510(k) clearance?

FOAM WEDGES received FDA 510(k) clearance on 1982-06-11, under 510(k) number K821647.

Who is the listed applicant for FOAM WEDGES?

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.