The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Xmax, Emax2 And Emax2 Plus System With Otologic Attachment System.
| Device ID | K131053 |
| 510k Number | K131053 |
| Device Name: | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | THE ANSPACH EFFORT, INC. 3012 ST. CHARLES DRIVE Tampa, FL 33618 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring THE ANSPACH EFFORT, INC. 3012 ST. CHARLES DRIVE Tampa, FL 33618 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-16 |
| Decision Date | 2013-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845384017691 | K131053 | 000 |
| 00845384017578 | K131053 | 000 |
| 00845384017561 | K131053 | 000 |
| 00845384017554 | K131053 | 000 |
| 00845384017547 | K131053 | 000 |
| 00845384017530 | K131053 | 000 |
| 00845384017523 | K131053 | 000 |
| 00845384017516 | K131053 | 000 |
| 00845384017509 | K131053 | 000 |
| 00845384017585 | K131053 | 000 |
| 00845384017592 | K131053 | 000 |
| 00845384017608 | K131053 | 000 |
| 00845384017684 | K131053 | 000 |
| 00845384017677 | K131053 | 000 |
| 00845384017660 | K131053 | 000 |
| 00845384017653 | K131053 | 000 |
| 00845384017646 | K131053 | 000 |
| 00845384017639 | K131053 | 000 |
| 00845384017622 | K131053 | 000 |
| 00845384017615 | K131053 | 000 |
| 00845384017493 | K131053 | 000 |