The following data is part of a premarket notification filed by Valley West, Inc. with the FDA for Trump-it Ii And Magnum 250.
| Device ID | K973814 |
| 510k Number | K973814 |
| Device Name: | TRUMP-IT II AND MAGNUM 250 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VALLEY WEST, INC. 300 NW 82ND AVENUE, SUITE 402 Plantation, FL 33324 |
| Contact | Julie H Byerly |
| Correspondent | Julie H Byerly VALLEY WEST, INC. 300 NW 82ND AVENUE, SUITE 402 Plantation, FL 33324 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1998-01-30 |
| Summary: | summary |