The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Pouch.
| Device ID | K992190 |
| 510k Number | K992190 |
| Device Name: | CORE POUCH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CORE DYNAMICS, INC. 11222 ST. JOHNS IND. PKWY. NORTH Jacksonville, FL 32246 -6675 |
| Contact | Thomas M Mcintosh |
| Correspondent | Thomas M Mcintosh CORE DYNAMICS, INC. 11222 ST. JOHNS IND. PKWY. NORTH Jacksonville, FL 32246 -6675 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-29 |
| Decision Date | 1999-09-01 |