Cleared Traditional

K873545 - PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT
(FDA 510(k) Clearance)

K873545 · Commercial Products & Engineering Co. · Dental

Nov 1987

Decision

80d

Days

Class 1

Risk

K873545 is an FDA 510(k) clearance for the PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT. This device is classified as a Evacuator, Oral Cavity (Class I — General Controls, product code EHZ).

Submitted by Commercial Products & Engineering Co. (Grand Rapids, US). The FDA issued a Cleared decision on November 20, 1987, 80 days after receiving the submission on September 1, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K873545 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 1987
Decision Date	November 20, 1987
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—