The following data is part of a premarket notification filed by American Optisurgical, Inc. with the FDA for Rm001 Reusable.
| Device ID | K953538 |
| 510k Number | K953538 |
| Device Name: | RM001 REUSABLE |
| Classification | Unit, Phacofragmentation |
| Applicant | AMERICAN OPTISURGICAL, INC. 19 HAMMOND SUITE 505 Irvine, CA 92718 |
| Contact | Herbert Cameron |
| Correspondent | Herbert Cameron AMERICAN OPTISURGICAL, INC. 19 HAMMOND SUITE 505 Irvine, CA 92718 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-12-26 |