The following data is part of a premarket notification filed by Sangstat Medical Corp. with the FDA for Cyclotech Cyclosporine Oral Solutions Dispenser.
| Device ID | K980109 |
| 510k Number | K980109 |
| Device Name: | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER |
| Classification | Dispenser, Liquid Medication |
| Applicant | SANGSTAT MEDICAL CORP. 6300 DUMBARTON CIRCLE Fremont, CA 94555 |
| Contact | Derek Williams |
| Correspondent | Derek Williams SANGSTAT MEDICAL CORP. 6300 DUMBARTON CIRCLE Fremont, CA 94555 |
| Product Code | KYX |
| CFR Regulation Number | 880.6430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-12 |
| Decision Date | 1998-08-18 |
| Summary: | summary |