The following data is part of a premarket notification filed by Roc Chinese-european Industrial Research Society with the FDA for Home Care Jelly.
| Device ID | K022494 |
| 510k Number | K022494 |
| Device Name: | HOME CARE JELLY |
| Classification | Media, Electroconductive |
| Applicant | ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY 2064 TAMARIN DR. Columbus, OH 43235 |
| Contact | Shu-chen Cheng |
| Correspondent | Shu-chen Cheng ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY 2064 TAMARIN DR. Columbus, OH 43235 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2002-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873684557 | K022494 | 000 |
| 04719873684540 | K022494 | 000 |