The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Or340 Intraoperative Ultrasound Biopsy Needle Guid.
| Device ID | K913987 |
| 510k Number | K913987 |
| Device Name: | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Donald A Lincoln |
| Correspondent | Donald A Lincoln Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1992-04-13 |