The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Kirwan Disposable 23khz Manifold Tubing, 40-3600, & 36khz Manifold Tubing, 40-3601.
| Device ID | K070360 |
| 510k Number | K070360 |
| Device Name: | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Contact | Kevin P Prario |
| Correspondent | Kevin P Prario KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-07 |
| Decision Date | 2007-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841019107734 | K070360 | 000 |
| 10841019107727 | K070360 | 000 |