The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Dissection Tools.
Device ID | K113476 |
510k Number | K113476 |
Device Name: | ANSPACH DISSECTION TOOLS |
Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
Contact | Jeannette G Dailey |
Correspondent | Jeannette G Dailey THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
Product Code | HBE |
CFR Regulation Number | 882.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-22 |
Decision Date | 2011-12-16 |
Summary: | summary |