The following data is part of a premarket notification filed by Plancon Instruments with the FDA for Plancon Microlamellar Keratome (single Piece Keratome Head With Accessories).
| Device ID | K970377 |
| 510k Number | K970377 |
| Device Name: | PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) |
| Classification | Keratome, Ac-powered |
| Applicant | PLANCON INSTRUMENTS 15 RUE GEORGES BESSE Anthony, FR 92160 |
| Contact | Alain Duprat |
| Correspondent | Alain Duprat PLANCON INSTRUMENTS 15 RUE GEORGES BESSE Anthony, FR 92160 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-03-31 |
| Summary: | summary |