The following data is part of a premarket notification filed by Enochs Mfg., Inc. with the FDA for Power Examination Table.
Device ID | K882010 |
510k Number | K882010 |
Device Name: | POWER EXAMINATION TABLE |
Classification | Table, Examination, Medical, Powered |
Applicant | ENOCHS MFG., INC. P.O. BOX 50199 Indianapolis, IN 46250 |
Contact | Charles D Kellam |
Correspondent | Charles D Kellam ENOCHS MFG., INC. P.O. BOX 50199 Indianapolis, IN 46250 |
Product Code | LGX |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-13 |
Decision Date | 1988-07-13 |