The following data is part of a premarket notification filed by Steinway Instrument Co., Inc. with the FDA for Steinway Micro-kerato-trephine.
| Device ID | K843646 |
| 510k Number | K843646 |
| Device Name: | STEINWAY MICRO-KERATO-TREPHINE |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | STEINWAY INSTRUMENT CO., INC. 5466 COMPLEX ST. #205 SAN DIEGO, CA 92123 |
| Contact | LOREN HENDRICKS |
| Correspondent | LOREN HENDRICKS STEINWAY INSTRUMENT CO., INC. 5466 COMPLEX ST. #205 SAN DIEGO, CA 92123 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1985-01-03 |