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 |