The following data is part of a premarket notification filed by Implant Corp. Of America with the FDA for Paralleling Guides.
| Device ID | K914715 |
| 510k Number | K914715 |
| Device Name: | PARALLELING GUIDES |
| Classification | Guide, Surgical, Instrument |
| 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 | FZX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1994-02-16 |