The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Board, Arm (with Cover).
Device ID | K864670 |
510k Number | K864670 |
Device Name: | BOARD, ARM (WITH COVER) |
Classification | Board, Arm (with Cover), Sterile |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Kathy Russell |
Correspondent | Kathy Russell ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | BTX |
CFR Regulation Number | 878.3910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-02 |
Decision Date | 1987-01-12 |