Dandy Hemostatic Forceps

FDA 510(k) K772389 · Edward Weck, Inc.

Substantially Equivalent

510(k) numberK772389

Submission

Device name
Dandy Hemostatic Forceps
Applicant
Edward Weck, Inc.
Mchenry, IL, US
Received
December 27, 1977
Decision date
January 6, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

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Questions and answers

When was Dandy Hemostatic Forceps cleared by the FDA?

Dandy Hemostatic Forceps (K772389) received a 510(k) decision of Substantially Equivalent on January 6, 1978, 10 days after the submission was received.

What is the product code of K772389?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.