The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for I.m. Retrograde Blades.
Device ID | K810045 |
510k Number | K810045 |
Device Name: | I.M. RETROGRADE BLADES |
Classification | Blade, Saw, General & Plastic Surgery, Surgical |
Applicant | HOGAN & HARTSON 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GFA |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-08 |
Decision Date | 1981-02-12 |