The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Sterilization Process/outerwrap.
| Device ID | K792633 |
| 510k Number | K792633 |
| Device Name: | STERILIZATION PROCESS/OUTERWRAP |
| Classification | Filters, Cell Collection, Tissue Processing |
| Applicant | PROCTER & GAMBLE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KET |
| CFR Regulation Number | 864.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-19 |
| Decision Date | 1980-01-11 |