The following data is part of a premarket notification filed by Neuro Resource Group, Inc. with the FDA for Interx 1000/derma 200 Stimulator For Cosmetic Use.
| Device ID | K070217 |
| 510k Number | K070217 |
| Device Name: | INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | NEURO RESOURCE GROUP, INC. 1100 JUPITER RD., STE. 190 Plano, TX 75074 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes NEURO RESOURCE GROUP, INC. 1100 JUPITER RD., STE. 190 Plano, TX 75074 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-23 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851894007336 | K070217 | 000 |