Cleared Traditional

SURGICAL OSCILLATING SAW

K760958 · American Safety Equipment Corp. · Dental

Nov 1976

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K760958 is an FDA 510(k) clearance for the SURGICAL OSCILLATING SAW, a Saw, Bone, Ac-powered (Class II — Special Controls, product code DZH), submitted by American Safety Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1976, 15 days after receiving the submission on November 1, 1976. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K760958 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1976
Decision Date	November 16, 1976
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—