The following data is part of a premarket notification filed by Soma Access Systems Llc with the FDA for Soma Access Systems Exacttrack Procedure Kit.
| Device ID | K113680 |
| 510k Number | K113680 |
| Device Name: | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SOMA ACCESS SYSTEMS LLC 109 LAUREN ROAD, SUITE 4C Greenville, SC 29607 |
| Contact | Genoa Atwood |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2011-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841517100156 | K113680 | 000 |
| 00841517100162 | K113680 | 000 |