The following data is part of a premarket notification filed by Aesculap-meditec North America with the FDA for Aesculap-meditec Slit Lamps Sl07 And Sl08.
| Device ID | K974467 |
| 510k Number | K974467 |
| Device Name: | AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | AESCULAP-MEDITEC NORTH AMERICA 23832 VIA MONTE Coto De Caza, CA 92679 -4001 |
| Contact | William T Kelley |
| Correspondent | William T Kelley AESCULAP-MEDITEC NORTH AMERICA 23832 VIA MONTE Coto De Caza, CA 92679 -4001 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-02-19 |
| Summary: | summary |