The following data is part of a premarket notification filed by Monarch Products, Inc. with the FDA for Monarch Sterilization Container System.
| Device ID | K850289 |
| 510k Number | K850289 |
| Device Name: | MONARCH STERILIZATION CONTAINER SYSTEM |
| 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 | 1985-01-24 |
| Decision Date | 1985-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995096175 | K850289 | 000 |
| 10724995002494 | K850289 | 000 |
| 10724995095878 | K850289 | 000 |
| 10724995095885 | K850289 | 000 |
| 10724995095908 | K850289 | 000 |
| 00724995095840 | K850289 | 000 |
| 00724995096083 | K850289 | 000 |
| 00724995096090 | K850289 | 000 |
| 00724995096106 | K850289 | 000 |
| 00724995096113 | K850289 | 000 |
| 00724995096120 | K850289 | 000 |
| 00724995096151 | K850289 | 000 |
| 00724995096168 | K850289 | 000 |
| 10724995002487 | K850289 | 000 |