The following data is part of a premarket notification filed by Leonard P. Linkow, D.d.l. with the FDA for Generation 5 Linkow Blade Implants.
Device ID | K822969 |
510k Number | K822969 |
Device Name: | GENERATION 5 LINKOW BLADE IMPLANTS |
Classification | Blade-form Endosseous Dental Implant |
Applicant | LEONARD P. LINKOW, D.D.L. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | NRQ |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-08 |
Decision Date | 1982-11-04 |