The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Endpoint 500 Peracetic Acid Test Indicators.
| Device ID | K931935 |
| 510k Number | K931935 |
| Device Name: | ENDPOINT 500 PERACETIC ACID TEST INDICATORS |
| Classification | Electrode, Electrosurgical |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Mark Aldana |
| Correspondent | Mark Aldana MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-19 |
| Decision Date | 1994-02-07 |