Cleared Traditional

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)

K952363 · Ela Medical, Inc. · Dental

Aug 1995

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K952363 is an FDA 510(k) clearance for the OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034), a Instrument, Hand, Calculus Removal (Class I — General Controls, product code ELA), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on August 15, 1995, 106 days after receiving the submission on May 1, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K952363 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1995
Decision Date	August 15, 1995
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF