Bray Rongeur

FDA 510(k) K954699 · Johnson & Johnson Professionals, Inc.

Substantially Equivalent

510(k) numberK954699

Submission

Device name
Bray Rongeur
Applicant
Johnson & Johnson Professionals, Inc.
Raritan, NJ, US
Received
October 12, 1995
Decision date
December 6, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAE – Rongeur, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4840
Specialty
Neurology

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Questions and answers

When was Bray Rongeur cleared by the FDA?

Bray Rongeur (K954699) received a 510(k) decision of Substantially Equivalent on December 6, 1995, 55 days after the submission was received.

What is the product code of K954699?

The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.