The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Microwave Automated Tissue Processor.
Device ID | K924590 |
510k Number | K924590 |
Device Name: | MICROWAVE AUTOMATED TISSUE PROCESSOR |
Classification | Processor, Tissue, Automated |
Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
Contact | Richard Crymes |
Correspondent | Richard Crymes 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 | 1992-09-10 |
Decision Date | 1992-12-29 |