The following data is part of a premarket notification filed by Medicalex with the FDA for Surgical Aspirator.
| Device ID | K850946 |
| 510k Number | K850946 |
| Device Name: | SURGICAL ASPIRATOR |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDICALEX 39 RUE CROULEBARBE Paris 75013, FR |
| Contact | Aldo Levy |
| Correspondent | Aldo Levy MEDICALEX 39 RUE CROULEBARBE Paris 75013, FR |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-07 |
| Decision Date | 1985-09-16 |