The following data is part of a premarket notification filed by Tri W-g, Inc. with the FDA for R1436,r1697,r1699,r1564,r1216,r1214,r854 & R1213.
Device ID | K861350 |
510k Number | K861350 |
Device Name: | R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213 |
Classification | Table, Mechanical |
Applicant | TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Contact | John Weber |
Correspondent | John Weber TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Product Code | INW |
CFR Regulation Number | 890.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-07 |
Decision Date | 1986-05-02 |