The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Micromax System.
Device ID | K965080 |
510k Number | K965080 |
Device Name: | ANSPACH MICROMAX SYSTEM |
Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
Contact | William E Anspach, Iii M.d. |
Correspondent | William E Anspach, Iii M.d. THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
Product Code | ERL |
CFR Regulation Number | 874.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-19 |
Decision Date | 1997-01-10 |