The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Hydradjust Ii Urological Table.
Device ID | K791699 |
510k Number | K791699 |
Device Name: | HYDRADJUST II UROLOGICAL TABLE |
Classification | Table, Cystometric, Non-electric And Accessories |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQS |
CFR Regulation Number | 876.4890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-29 |
Decision Date | 1979-10-22 |