The following data is part of a premarket notification filed by Implant Corp. Of America with the FDA for Bone Drills Or Taps.
Device ID | K914714 |
510k Number | K914714 |
Device Name: | BONE DRILLS OR TAPS |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLANT CORP. OF AMERICA 2299 9TH AVE. NORTH, SUITE 1-E St. Petersburg, FL 33713 |
Contact | O.hilt Tatum |
Correspondent | O.hilt Tatum IMPLANT CORP. OF AMERICA 2299 9TH AVE. NORTH, SUITE 1-E St. Petersburg, FL 33713 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-18 |
Decision Date | 1993-11-15 |