Cleared Traditional

MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

K001219 · Biomedical Ent., Inc. · Dental

Jun 2000

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K001219 is an FDA 510(k) clearance for the MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on June 21, 2000, 65 days after receiving the submission on April 17, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K001219 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2000
Decision Date	June 21, 2000
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF