The following data is part of a premarket notification filed by Arthro-medic, Inc. with the FDA for Williams Belt & Boot.
Device ID | K891387 |
510k Number | K891387 |
Device Name: | WILLIAMS BELT & BOOT |
Classification | Table, Surgical With Orthopedic Accessories, Manual |
Applicant | ARTHRO-MEDIC, INC. 4203 BELFORT RD., SUITE 150 Jacksonville, FL 32216 |
Contact | Webster William,jr |
Correspondent | Webster William,jr ARTHRO-MEDIC, INC. 4203 BELFORT RD., SUITE 150 Jacksonville, FL 32216 |
Product Code | JEB |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-14 |
Decision Date | 1989-05-23 |