The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Modification To Spsmedical Sporview Bacterial Spore Strip.
| Device ID | K041099 |
| 510k Number | K041099 |
| Device Name: | MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-05-06 |
| Summary: | summary |