The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Endoscopic Transmural Suture Needle Set.
| Device ID | K932118 |
| 510k Number | K932118 |
| Device Name: | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Contact | Bill Dennis |
| Correspondent | Bill Dennis CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-03 |
| Decision Date | 1994-03-17 |