The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Sporview Bacterial Spore Strip.
| Device ID | K023716 |
| 510k Number | K023716 |
| Device Name: | 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 | 2002-11-05 |
| Decision Date | 2002-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B234FRGSTMS400634 | K023716 | 000 |
| B234FRGSTMS400633 | K023716 | 000 |
| 50732224000461 | K023716 | 000 |
| 10732224000432 | K023716 | 000 |
| 10732224000418 | K023716 | 000 |
| 50732224000409 | K023716 | 000 |
| 50732224000393 | K023716 | 000 |