The following data is part of a premarket notification filed by Med-tech Develoment Corp. with the FDA for Sapphire Blade Surgical Knife.
| Device ID | K860852 |
| 510k Number | K860852 |
| Device Name: | SAPPHIRE BLADE SURGICAL KNIFE |
| Classification | Knife, Ophthalmic |
| Applicant | MED-TECH DEVELOMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Contact | Jose H Bedoya |
| Correspondent | Jose H Bedoya MED-TECH DEVELOMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-07 |
| Decision Date | 1986-03-28 |