The following data is part of a premarket notification filed by Kli with the FDA for 12mm Self-sealing Trocar & Cannula.
| Device ID | K771958 |
| 510k Number | K771958 |
| Device Name: | 12MM SELF-SEALING TROCAR & CANNULA |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KLI 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-17 |
| Decision Date | 1977-10-25 |