The following data is part of a premarket notification filed by Percutaneous Systems, Inc. with the FDA for Coaxial Accordion Stone Management Device, Model: Coac12005 - Coa20015.
| Device ID | K082803 |
| 510k Number | K082803 |
| Device Name: | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | PERCUTANEOUS SYSTEMS, INC. 3260 HILLVIEW AVE. Palo Alto, CA 94304 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson PERCUTANEOUS SYSTEMS, INC. 3260 HILLVIEW AVE. Palo Alto, CA 94304 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2008-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857252004016 | K082803 | 000 |
| 00857252004009 | K082803 | 000 |