The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Chin (mentoplasty) Implants.
Device ID | K831724 |
510k Number | K831724 |
Device Name: | CHIN (MENTOPLASTY) IMPLANTS |
Classification | Prosthesis, Chin, Internal |
Applicant | S. JACKSON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FWP |
CFR Regulation Number | 878.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-31 |
Decision Date | 1983-08-12 |