The following data is part of a premarket notification filed by Abtox, Inc. with the FDA for Plazlyte(tm).
| Device ID | K905119 |
| 510k Number | K905119 |
| Device Name: | PLAZLYTE(TM) |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | ABTOX, INC. 104 TERRACE DR. Mundelein, IL 60060 |
| Contact | Ross A Caputo |
| Correspondent | Ross A Caputo ABTOX, INC. 104 TERRACE DR. Mundelein, IL 60060 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-14 |
| Decision Date | 1994-12-22 |