The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Trocar & Trocar Sleeeve 11mm, 10mm, 8mm & 5mm.
| Device ID | K915297 |
| 510k Number | K915297 |
| Device Name: | TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-02-11 |