The following data is part of a premarket notification filed by Ascon Medical Instruments, Ltd. with the FDA for Contact Lens Loupe, Inspetion Loupe.
| Device ID | K852054 |
| 510k Number | K852054 |
| Device Name: | CONTACT LENS LOUPE, INSPETION LOUPE |
| Classification | Gauge, Lens, Ophthalmic |
| Applicant | ASCON MEDICAL INSTRUMENTS, LTD. 825 N. CASS AVE., SUITE 208 Westmont, IL 60559 |
| Contact | Ravi Nallakrishnan |
| Correspondent | Ravi Nallakrishnan ASCON MEDICAL INSTRUMENTS, LTD. 825 N. CASS AVE., SUITE 208 Westmont, IL 60559 |
| Product Code | HLN |
| CFR Regulation Number | 886.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-09-05 |