The following data is part of a premarket notification filed by Life Enhancement Technologies, Llc. with the FDA for Karlson Ozone Sterilizer Model 100b.
| Device ID | K873200 |
| 510k Number | K873200 |
| Device Name: | KARLSON OZONE STERILIZER MODEL 100B |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | LIFE ENHANCEMENT TECHNOLOGIES, LLC. 2926 STATE ST. Erie, PA 16508 |
| Contact | Eskil L Karlson |
| Correspondent | Eskil L Karlson LIFE ENHANCEMENT TECHNOLOGIES, LLC. 2926 STATE ST. Erie, PA 16508 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-13 |
| Decision Date | 1989-01-27 |