The following data is part of a premarket notification filed by Kolberg Ocular Products, Inc. with the FDA for Kolberg Ophthalmic Conformer.
| Device ID | K945110 |
| 510k Number | K945110 |
| Device Name: | KOLBERG OPHTHALMIC CONFORMER |
| Classification | Conformer, Ophthalmic |
| Applicant | KOLBERG OCULAR PRODUCTS, INC. 9663 TIERRA GRANDE ST., SUITE 201 San Diego, CA 92126 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon KOLBERG OCULAR PRODUCTS, INC. 9663 TIERRA GRANDE ST., SUITE 201 San Diego, CA 92126 |
| Product Code | HQN |
| CFR Regulation Number | 886.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1995-01-13 |