The following data is part of a premarket notification filed by Ophtec Usa with the FDA for Ophtec Enclavation Needle.
| Device ID | K030471 |
| 510k Number | K030471 |
| Device Name: | OPHTEC ENCLAVATION NEEDLE |
| Classification | Hook, Ophthalmic |
| Applicant | OPHTEC USA 6421 CONGRESS AVE. STE 112 Boca Raton, FL 33487 |
| Contact | Rick Mccarley |
| Correspondent | Rick Mccarley OPHTEC USA 6421 CONGRESS AVE. STE 112 Boca Raton, FL 33487 |
| Product Code | HNQ |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-12 |
| Decision Date | 2003-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717819049176 | K030471 | 000 |