The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Disposable Suction/irrigation Tubing.
| Device ID | K910246 |
| 510k Number | K910246 |
| Device Name: | CORE DISPOSABLE SUCTION/IRRIGATION TUBING |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CORE DYNAMICS, INC. 9951 ATLANTIC BLVD. SUITE 318 Jacksonville, FL 32225 |
| Contact | Tim Reis |
| Correspondent | Tim Reis CORE DYNAMICS, INC. 9951 ATLANTIC BLVD. SUITE 318 Jacksonville, FL 32225 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-04-29 |