The following data is part of a premarket notification filed by Med General with the FDA for Medgeneral Single-use Bulldog.
Device ID | K782006 |
510k Number | K782006 |
Device Name: | MEDGENERAL SINGLE-USE BULLDOG |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | MED GENERAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-01 |
Decision Date | 1978-12-15 |