The following data is part of a premarket notification filed by Monarch Products, Inc. with the FDA for Monarch Sterilization Container Syst, Modification.
| Device ID | K911760 |
| 510k Number | K911760 |
| Device Name: | MONARCH STERILIZATION CONTAINER SYST, MODIFICATION |
| Classification | Wrap, Sterilization |
| Applicant | MONARCH PRODUCTS, INC. P.O. BOX 1899 Jacksonville, TX 75766 |
| Contact | Rodney D Constant |
| Correspondent | Rodney D Constant MONARCH PRODUCTS, INC. P.O. BOX 1899 Jacksonville, TX 75766 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-06-24 |