The following data is part of a premarket notification filed by Ferno-washington, Inc. with the FDA for Model 668, Traction Splint, Adult.
Device ID | K864765 |
510k Number | K864765 |
Device Name: | MODEL 668, TRACTION SPLINT, ADULT |
Classification | Apparatus, Traction, Non-powered |
Applicant | FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington, OH 45177 |
Contact | Eric N Besanko |
Correspondent | Eric N Besanko FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington, OH 45177 |
Product Code | HST |
CFR Regulation Number | 888.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-05 |
Decision Date | 1986-12-17 |