The following data is part of a premarket notification filed by Pako Corp. with the FDA for Pakostat Ii.
| Device ID | K760846 |
| 510k Number | K760846 |
| Device Name: | PAKOSTAT II |
| Classification | Dryer, Film, Radiographic |
| Applicant | PAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EGW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-15 |
| Decision Date | 1977-01-07 |