The following data is part of a premarket notification filed by Med General with the FDA for Single-use Mini-bulldog.
Device ID | K791098 |
510k Number | K791098 |
Device Name: | SINGLE-USE MINI-BULLDOG |
Classification | Clamp, Vascular |
Applicant | MED GENERAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-12 |
Decision Date | 1979-06-22 |