The following data is part of a premarket notification filed by Vermont Wood Industries, Inc. with the FDA for Splint Wood.
Device ID | K832144 |
510k Number | K832144 |
Device Name: | SPLINT WOOD |
Classification | Splint, Hand, And Components |
Applicant | VERMONT WOOD INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILH |
CFR Regulation Number | 890.3475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-30 |
Decision Date | 1983-08-01 |