The following data is part of a premarket notification filed by Crosstex International with the FDA for Spsmedical Vh2o2 Indicator Strips, Indicator Labels, Indicator Tape.
| Device ID | K140566 |
| 510k Number | K140566 |
| Device Name: | SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | CROSSTEX INTERNATIONAL 6789 WEST HENRIETTA ROAD Rush, NY 14543 |
| Contact | Michael G Nolan |
| Correspondent | Michael G Nolan CROSSTEX INTERNATIONAL 6789 WEST HENRIETTA ROAD Rush, NY 14543 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10732224750993 | K140566 | 000 |
| 50732224734137 | K140566 | 000 |
| 10732224710621 | K140566 | 000 |
| 10732224710577 | K140566 | 000 |