FDA 510(k)

OPERATING ROOM PROCEDURAL PACK

K-Number: K822804 · 1982-12-28

ApplicantAdicon

Decision Date1982-12-28

Product Code

DecisionSubstantially Equivalent

Device Summary

OPERATING ROOM PROCEDURAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Adicon. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K822804. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERATING ROOM PROCEDURAL PACK?

OPERATING ROOM PROCEDURAL PACK is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Adicon. The 510(k) number is K822804.

When did OPERATING ROOM PROCEDURAL PACK receive FDA 510(k) clearance?

OPERATING ROOM PROCEDURAL PACK received FDA 510(k) clearance on 1982-12-28, under 510(k) number K822804.

Who is the listed applicant for OPERATING ROOM PROCEDURAL PACK?

The FDA 510(k) record lists Adicon 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.