The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Rapicide Opa-28.
| Device ID | K120306 |
| 510k Number | K120306 |
| Device Name: | RAPICIDE OPA-28 |
| Classification | Sterilant, Medical Devices |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Brent Greiger, Ms, Rac |
| Correspondent | Brent Greiger, Ms, Rac MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-01 |
| Decision Date | 2012-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10612479185989 | K120306 | 000 |
| 30677964054267 | K120306 | 000 |
| 10304040005368 | K120306 | 000 |