The following data is part of a premarket notification filed by Ritmed, Inc. with the FDA for Securet Drape & Instrument Retainer/incl.
Device ID | K830276 |
510k Number | K830276 |
Device Name: | SECURET DRAPE & INSTRUMENT RETAINER/INCL |
Classification | Antisera, All Types, Klebsiella Spp. |
Applicant | RITMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GTC |
CFR Regulation Number | 866.3340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-25 |
Decision Date | 1983-03-29 |