The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Lithovac Suction/aspiration Probe.
| Device ID | K964111 |
| 510k Number | K964111 |
| Device Name: | LITHOVAC SUCTION/ASPIRATION PROBE |
| Classification | Evacuator, Gastro-urology |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KQT |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1996-12-16 |
| Summary: | summary |