The following data is part of a premarket notification filed by Sheathing Technologies, Inc. with the FDA for Sheathes Needle Guide, Model Ng-sr-a-484-kit (there Will Be Various Model Numbers Based On Transducer And Cover).
| Device ID | K043425 |
| 510k Number | K043425 |
| Device Name: | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DR. Morgan Hill, CA 95037 |
| Contact | Larry Polayes |
| Correspondent | Larry Polayes SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DR. Morgan Hill, CA 95037 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-02-28 |
| Summary: | summary |