The following data is part of a premarket notification filed by Interphase Implants, Inc. with the FDA for Smooth Staple Implant.
Device ID | K900433 |
510k Number | K900433 |
Device Name: | SMOOTH STAPLE IMPLANT |
Classification | Implant, Transmandibular |
Applicant | INTERPHASE IMPLANTS, INC. 19928 FARMINGTON RD. Livonia, MI 48152 |
Contact | Knapp Dds |
Correspondent | Knapp Dds INTERPHASE IMPLANTS, INC. 19928 FARMINGTON RD. Livonia, MI 48152 |
Product Code | MDL |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-11-16 |