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 |