The following data is part of a premarket notification filed by Ohio Medical Corporation with the FDA for Care-e-vac 3.
| Device ID | K062610 |
| 510k Number | K062610 |
| Device Name: | CARE-E-VAC 3 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | OHIO MEDICAL CORPORATION 1111 LAKESIDE DR. Gurnee, IL 60031 |
| Contact | Hoby Chae |
| Correspondent | Hoby Chae OHIO MEDICAL CORPORATION 1111 LAKESIDE DR. Gurnee, IL 60031 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2006-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08688250002436 | K062610 | 000 |
| 00628101609351 | K062610 | 000 |