The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for Thera-cream, Model Tct004.
| Device ID | K032239 |
| 510k Number | K032239 |
| Device Name: | THERA-CREAM, MODEL TCT004 |
| Classification | Media, Electroconductive |
| Applicant | PRIZM MEDICAL, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens PRIZM MEDICAL, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2004-07-30 |
| Summary: | summary |