The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Sporview Pa Culture Set.
| Device ID | K043135 |
| 510k Number | K043135 |
| Device Name: | SPSMEDICAL SPORVIEW PA CULTURE SET |
| Classification | Indicator, Biological, Liquid Chemical Sterilization Process |
| Applicant | SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543 |
| Contact | Gary J Scola |
| Correspondent | Gary J Scola SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543 |
| Product Code | MRB |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2005-01-13 |
| Summary: | summary |