The following data is part of a premarket notification filed by Bemis Health Care with the FDA for Bemis Sterile-case For Use W/ethylene Oxide Steri..
| Device ID | K885019 |
| 510k Number | K885019 |
| Device Name: | BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. |
| Classification | Wrap, Sterilization |
| Applicant | BEMIS HEALTH CARE 300 MILL ST. P.O. BOX 901 Sheboygan Falls, WI 53085 |
| Contact | Jane M Turner |
| Correspondent | Jane M Turner BEMIS HEALTH CARE 300 MILL ST. P.O. BOX 901 Sheboygan Falls, WI 53085 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-29 |
| Decision Date | 1989-01-25 |