The following data is part of a premarket notification filed by Vvortex International Corp. with the FDA for Fisk Arm Support.
| Device ID | K931876 |
| 510k Number | K931876 |
| Device Name: | FISK ARM SUPPORT |
| Classification | Table, Operating-room, Pneumatic |
| Applicant | VVORTEX INTERNATIONAL CORP. 11321 TRADE CENTER DR., SUITE 260 Rancho Cordova, CA 95742 |
| Contact | Shane Fisk |
| Correspondent | Shane Fisk VVORTEX INTERNATIONAL CORP. 11321 TRADE CENTER DR., SUITE 260 Rancho Cordova, CA 95742 |
| Product Code | FWW |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-14 |
| Decision Date | 1993-09-09 |