The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Pressure Steam Sterilizers.
| Device ID | K895848 |
| 510k Number | K895848 |
| Device Name: | PRESSURE STEAM STERILIZERS |
| Classification | Sterilizer, Steam |
| Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Contact | Lipton, Phd |
| Correspondent | Lipton, Phd SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-11 |