The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Sporview Steam Bi.
| Device ID | K111515 |
| 510k Number | K111515 |
| Device Name: | SPSMEDICAL SPORVIEW STEAM BI |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543 |
| Contact | Gary J Socola |
| Correspondent | Gary J Socola SPS MEDICAL SUPPLY CORP. 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 | 2011-06-01 |
| Decision Date | 2012-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D72310274783 | K111515 | 000 |
| 10732224721238 | K111515 | 000 |
| 10732224720965 | K111515 | 000 |
| 10732224720934 | K111515 | 000 |
| 10732224720927 | K111515 | 000 |
| 10732224720125 | K111515 | 000 |
| 10732224720118 | K111515 | 000 |
| 10732224000456 | K111515 | 000 |
| 00060705811530 | K111515 | 000 |
| 10732224721245 | K111515 | 000 |
| 10732224721450 | K111515 | 000 |
| 00732224721521 | K111515 | 000 |
| D72310274663 | K111515 | 000 |
| 40612479163599 | K111515 | 000 |
| 20612479163601 | K111515 | 000 |
| 20612479159154 | K111515 | 000 |
| 20612479159130 | K111515 | 000 |
| 00732224757490 | K111515 | 000 |
| 00732224757476 | K111515 | 000 |
| 10732224721542 | K111515 | 000 |
| 50732224000447 | K111515 | 000 |