The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Quarter Globe Caps.
Device ID | K831727 |
510k Number | K831727 |
Device Name: | QUARTER GLOBE CAPS |
Classification | Mesh, Surgical |
Applicant | S. JACKSON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-31 |
Decision Date | 1983-08-12 |