The following data is part of a premarket notification filed by Implant Center Of The Palm Beaches with the FDA for Wide Screws Tp-4k, Pros-g4, Tools G4 Or 17-4 Ss.
Device ID | K952988 |
510k Number | K952988 |
Device Name: | WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLANT CENTER OF THE PALM BEACHES 824 US HWY I, STE. 370 N. Palm Beach, FL 33408 |
Contact | Jack T Krauser |
Correspondent | Jack T Krauser IMPLANT CENTER OF THE PALM BEACHES 824 US HWY I, STE. 370 N. Palm Beach, FL 33408 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-23 |
Decision Date | 1995-07-26 |