The following data is part of a premarket notification filed by Karl M. Block Co. with the FDA for Keith-a.r.v..
Device ID | K851444 |
510k Number | K851444 |
Device Name: | KEITH-A.R.V. |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | KARL M. BLOCK CO. 567 HANLEY INDUSTRIAL COURT St. Louis, MO 63144 |
Contact | Keith |
Correspondent | Keith KARL M. BLOCK CO. 567 HANLEY INDUSTRIAL COURT St. Louis, MO 63144 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-11 |
Decision Date | 1985-05-10 |