The following data is part of a premarket notification filed by M. Imonti And Associates Inc., with the FDA for Pro-pak For Oms Diplomate.
| Device ID | K950800 |
| 510k Number | K950800 |
| Device Name: | PRO-PAK FOR OMS DIPLOMATE |
| Classification | Unit, Phacofragmentation |
| Applicant | M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Contact | Maurice Imonti |
| Correspondent | Maurice Imonti M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-05-22 |