The following data is part of a premarket notification filed by Spsmedical Supply Corp. A Division Of Cantel Medical with the FDA for Sporview Vh202 Bi.
Device ID | K171287 |
510k Number | K171287 |
Device Name: | Sporview VH202 BI |
Classification | Indicator, Biological Sterilization Process |
Applicant | SPSmedical Supply Corp. A Division Of Cantel Medical 6789 West Henrietta Rd Rush, NY 14543 |
Contact | Brent Geiger |
Correspondent | Brent Geiger SPSmedical Supply Corp. A Division Of Cantel Medical 6789 West Henrietta Rd 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 | 2017-05-01 |
Decision Date | 2018-02-01 |
Summary: | summary |