The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Suction/irrigation Cannula; Catlog #532.00.
| Device ID | K915298 |
| 510k Number | K915298 |
| Device Name: | SUCTION/IRRIGATION CANNULA; CATLOG #532.00 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 400 LATHROP AVE. SUITE 200 River Forest, IL 60305 |
| Contact | Douglas Hulfish |
| Correspondent | Douglas Hulfish LIFEGUARD MEDICAL PRODUCTS, INC. 400 LATHROP AVE. SUITE 200 River Forest, IL 60305 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-01-23 |