The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Dynamics Laparoscipic Irrigation Pump.
| Device ID | K931138 |
| 510k Number | K931138 |
| Device Name: | CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1993-09-07 |