Cleared Traditional

K760960 - SURGICAL WIRE DRIVER
(FDA 510(k) Clearance)

K760960 · American Safety Equipment Corp. · Dental device

Nov 1976

Decision

18d

Days

Class 2

Risk

K760960 is an FDA 510(k) clearance for the SURGICAL WIRE DRIVER. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).

Submitted by American Safety Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1976, 18 days after receiving the submission on November 1, 1976.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K760960 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 01, 1976
Decision Date	November 19, 1976
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—