The following data is part of a premarket notification filed by Alternative Pioneering Research And Development with the FDA for Saniclave 200.
| Device ID | K112811 |
| 510k Number | K112811 |
| Device Name: | SANICLAVE 200 |
| Classification | Sterilizer, Steam |
| Applicant | ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT 17319 LAKE BLVD. Shafer, MN 55074 |
| Contact | Isaac Erickson |
| Correspondent | Isaac Erickson ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT 17319 LAKE BLVD. Shafer, MN 55074 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-01-11 |
| Summary: | summary |