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 |