The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Emax Drill System.
Device ID | K011444 |
510k Number | K011444 |
Device Name: | ANSPACH EMAX DRILL SYSTEM |
Classification | Motor, Drill, Electric |
Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
Contact | William E Anspach |
Correspondent | William E Anspach THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
Product Code | HBC |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-11 |
Decision Date | 2001-08-08 |