The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Lx 300 Tissue Processor.
| Device ID | K853938 |
| 510k Number | K853938 |
| Device Name: | LX 300 TISSUE PROCESSOR |
| Classification | Processor, Tissue, Automated |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
| Contact | Joseph Catarious |
| Correspondent | Joseph Catarious INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
| Product Code | IEO |
| CFR Regulation Number | 864.3875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-10-10 |