The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for Prizm Medical, Inc. Micro-z Stimulation System.
| Device ID | K024181 |
| 510k Number | K024181 |
| Device Name: | PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PRIZM MEDICAL, INC. 5536 TROWBRIDGE DR. Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria PRIZM MEDICAL, INC. 5536 TROWBRIDGE DR. Dunwoody, GA 30338 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-19 |
| Decision Date | 2003-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B872MZS2KIT20 | K024181 | 000 |
| B872MZM1000 | K024181 | 000 |
| D20007 | K024181 | 000 |