The following data is part of a premarket notification filed by Ritmed, Inc. with the FDA for Protet Holders-blocks & Roll.
Device ID | K830272 |
510k Number | K830272 |
Device Name: | PROTET HOLDERS-BLOCKS & ROLL |
Classification | Operating Room Accessories Table Tray |
Applicant | RITMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-25 |
Decision Date | 1983-06-03 |