The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Sporview Steam Bi Test Pack.
| Device ID | K022706 |
| 510k Number | K022706 |
| Device Name: | SPSMEDICAL SPORVIEW STEAM BI TEST PACK |
| 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 | 2002-08-14 |
| Decision Date | 2002-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950002664 | K022706 | 000 |
| 10889950002657 | K022706 | 000 |
| 10889950002671 | K022706 | 000 |