The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Elan 4 Motor System.
Device ID | K152960 |
510k Number | K152960 |
Device Name: | ELAN 4 Motor System |
Classification | Motor, Drill, Electric |
Applicant | AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
Contact | Peter Stoll |
Correspondent | Peter Stoll AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
Product Code | HBC |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-07 |
Decision Date | 2016-07-22 |
Summary: | summary |