The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Implant Ports W/attach Hi Perf Groshong Cath.
| Device ID | K913235 |
| 510k Number | K913235 |
| Device Name: | DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH |
| Classification | Syringe, Piston |
| Applicant | DAVOL, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Jack Speer |
| Correspondent | Jack Speer DAVOL, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-10-31 |