The following data is part of a premarket notification filed by Appasamy Associates with the FDA for Appasamy Slit Lamp, A1a-11 And A1a-12 Series.
| Device ID | K082031 |
| 510k Number | K082031 |
| Device Name: | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | APPASAMY ASSOCIATES 20, SBI OFFICERS COLONY 1ST STREET Arumbakkam, Chennai, IN 600 106 |
| Contact | R.n. Kasthuri |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-17 |
| Decision Date | 2008-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869228000427 | K082031 | 000 |
| 00869228000410 | K082031 | 000 |
| 03664188000091 | K082031 | 000 |
| 03664188000015 | K082031 | 000 |
| 03664188000008 | K082031 | 000 |