The following data is part of a premarket notification filed by Reprocessing Products Corp. with the FDA for Ultra Low Total Chlorine, E-z Chek Sensitive Total Chlorine.
| Device ID | K090338 |
| 510k Number | K090338 |
| Device Name: | ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. Maple Grove, MN 55311 |
| Contact | Wally Jansen |
| Correspondent | Wally Jansen REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. Maple Grove, MN 55311 |
| Product Code | MSY |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-10 |
| Decision Date | 2009-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858293006090 | K090338 | 000 |
| 00858293006083 | K090338 | 000 |
| 00858293006076 | K090338 | 000 |
| 00858293006069 | K090338 | 000 |
| 10858293006059 | K090338 | 000 |
| 30858293006046 | K090338 | 000 |
| 10858293006035 | K090338 | 000 |