The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Tissue Processing System.
Device ID | K801513 |
510k Number | K801513 |
Device Name: | TISSUE PROCESSING SYSTEM |
Classification | Processor, Tissue, Automated |
Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IEO |
CFR Regulation Number | 864.3875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-30 |
Decision Date | 1980-07-28 |