The following data is part of a premarket notification filed by Altoona Medical Supply with the FDA for Fujitens Iii.
Device ID | K893874 |
510k Number | K893874 |
Device Name: | FUJITENS III |
Classification | Instrument, Dowel Cutting |
Applicant | ALTOONA MEDICAL SUPPLY 705 2ND AVE., S.W. Altoona, IA 50009 |
Contact | Donald Mackenzie |
Correspondent | Donald Mackenzie ALTOONA MEDICAL SUPPLY 705 2ND AVE., S.W. Altoona, IA 50009 |
Product Code | GZQ |
CFR Regulation Number | 882.4275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-26 |
Decision Date | 1989-12-22 |