Cleared Traditional

K760959 - SURGICAL CHISEL (FDA 510(k) Clearance)

K760959 · American Safety Equipment Corp. · Dental device

Nov 1976

Decision

14d

Days

Class 1

Risk

K760959 is an FDA 510(k) clearance for the SURGICAL CHISEL. This device is classified as a Chisel, Osteotome, Surgical (Class I - General Controls, product code EMM).

Submitted by American Safety Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976, 14 days after receiving the submission on November 1, 1976.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K760959 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 01, 1976
Decision Date	November 15, 1976
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—