The following data is part of a premarket notification filed by Minitube Of America, Inc with the FDA for Octax Laser Shot System.
| Device ID | K062524 |
| 510k Number | K062524 |
| Device Name: | OCTAX LASER SHOT SYSTEM |
| Classification | System, Assisted Reproduction Laser |
| Applicant | MINITUBE OF AMERICA, INC 419 VENTURE COURT Verona, WI 53593 |
| Contact | Frederick Kikkers |
| Correspondent | Frederick Kikkers MINITUBE OF AMERICA, INC 419 VENTURE COURT Verona, WI 53593 |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2006-12-15 |
| Summary: | summary |