The following data is part of a premarket notification filed by Alternative Pioneering Research And Development with the FDA for Saniclave 102, Model Rs-sc-102.
Device ID | K122978 |
510k Number | K122978 |
Device Name: | SANICLAVE 102, MODEL RS-SC-102 |
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 | 2012-09-26 |
Decision Date | 2013-05-23 |
Summary: | summary |