The following data is part of a premarket notification filed by Vinyl Technology, Inc. with the FDA for Inflatable Foot & Ankle Splint.
| Device ID | K874050 |
| 510k Number | K874050 |
| Device Name: | INFLATABLE FOOT & ANKLE SPLINT |
| Classification | Splint, Extremity, Inflatable, External |
| Applicant | VINYL TECHNOLOGY, INC. 2110 EDWARDS AVE. So. El Monte, CA 91733 |
| Contact | Carlos A Mollura |
| Correspondent | Carlos A Mollura VINYL TECHNOLOGY, INC. 2110 EDWARDS AVE. So. El Monte, CA 91733 |
| Product Code | FZF |
| CFR Regulation Number | 878.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-11-23 |