Tissure Retractors

FDA 510(k) K791122 · Xomed, Inc.

Substantially Equivalent

510(k) numberK791122

Submission

Device name
Tissure Retractors
Applicant
Xomed, Inc.
Arnold, MO, US
Received
June 15, 1979
Decision date
July 10, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GAD – Retractor
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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Questions and answers

When was Tissure Retractors cleared by the FDA?

Tissure Retractors (K791122) received a 510(k) decision of Substantially Equivalent on July 10, 1979, 25 days after the submission was received.

What is the product code of K791122?

The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.