The following data is part of a premarket notification filed by W. C. Green, D.d.s. with the FDA for Sitz Bath.
Device ID | K862600 |
510k Number | K862600 |
Device Name: | SITZ BATH |
Classification | Bath, Sitz, Nonpowered |
Applicant | W. C. GREEN, D.D.S. 103 WOODROW WILSON DR. Valdosta, GA 31601 |
Product Code | KTC |
CFR Regulation Number | 890.5125 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-08 |
Decision Date | 1986-07-18 |