The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Trocars, Trocar Sleeves And Reduction Sleeves.
| Device ID | K942389 |
| 510k Number | K942389 |
| Device Name: | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-18 |
| Decision Date | 1996-02-16 |