The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Ocm-g1 Attachment.
| Device ID | K180063 |
| 510k Number | K180063 |
| Device Name: | OCM-G1 Attachment |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Tamara J West |
| Correspondent | Tamara J West The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-09 |
| Decision Date | 2018-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845384017721 | K180063 | 000 |