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 |