The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Sporview 10 Steam Self Contained Biological Indicator.
| Device ID | K122024 |
| 510k Number | K122024 |
| Device Name: | SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | SPS MEDICAL SUPPLY CORP. 6789 W Henrietta Rd Industry, NY 14543 |
| Contact | Gary J Socola |
| Correspondent | Gary J Socola SPS MEDICAL SUPPLY CORP. 6789 W Henrietta Rd Industry, 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 | 2012-07-11 |
| Decision Date | 2013-11-26 |
| Summary: | summary |