The following data is part of a premarket notification filed by Koken Mfg Company, Inc. with the FDA for Dr7700 Operating Table.
Device ID | K864325 |
510k Number | K864325 |
Device Name: | DR7700 OPERATING TABLE |
Classification | Table, Operating-room, Ac-powered |
Applicant | KOKEN MFG COMPANY, INC. P.O. BOX 265 St. Louis, MO 63166 |
Contact | Masaya Kosaka |
Correspondent | Masaya Kosaka KOKEN MFG COMPANY, INC. P.O. BOX 265 St. Louis, MO 63166 |
Product Code | FQO |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-03 |
Decision Date | 1986-11-19 |