The following data is part of a premarket notification filed by Crosstex/spsmedical, A Division Of Cantel Medical with the FDA for Sporview Rapid Read Biological Indicator.
Device ID | K172432 |
510k Number | K172432 |
Device Name: | SporView Rapid Read Biological Indicator |
Classification | Indicator, Biological Sterilization Process |
Applicant | Crosstex/SPSmedical, A Division Of Cantel Medical 6789 West Henrietta Road Rush, NY 14543 |
Contact | Megan Skaar |
Correspondent | Megan Skaar Crosstex/SPSmedical, A Division Of Cantel Medical 6789 West Henrietta Road Rush, NY 14543 |
Product Code | FRC |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-11 |
Decision Date | 2017-12-12 |
Summary: | summary |