The following data is part of a premarket notification filed by Medical Technology Development Corp. with the FDA for Fixation Instruments.
| Device ID | K863727 |
| 510k Number | K863727 |
| Device Name: | FIXATION INSTRUMENTS |
| Classification | Forceps, Ophthalmic |
| Applicant | MEDICAL TECHNOLOGY DEVELOPMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Contact | Jose H Bedoya |
| Correspondent | Jose H Bedoya MEDICAL TECHNOLOGY DEVELOPMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-10-31 |