The following data is part of a premarket notification filed by Lysonix, Inc. with the FDA for Lysonix Ttd Delta Scavenger Suction/aspiration Cannulas Lysonix Infusion Diamond Cannulas.
| Device ID | K972958 |
| 510k Number | K972958 |
| Device Name: | LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LYSONIX, INC. 1170 MARK AVE. Carpinteria, CA 93013 |
| Contact | Michael J Sarrasin |
| Correspondent | Michael J Sarrasin LYSONIX, INC. 1170 MARK AVE. Carpinteria, CA 93013 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-09-19 |
| Summary: | summary |