The following data is part of a premarket notification filed by Reprocessing Products Corporation (rpc) with the FDA for E-z Check Ozone Test Strips.
| Device ID | K132344 |
| 510k Number | K132344 |
| Device Name: | E-Z CHECK OZONE TEST STRIPS |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | REPROCESSING PRODUCTS CORPORATION (RPC) 1643 W. MODERN COURT Tucson, AZ 85705 |
| Contact | Michael Honstein |
| Correspondent | Michael Honstein REPROCESSING PRODUCTS CORPORATION (RPC) 1643 W. MODERN COURT Tucson, AZ 85705 |
| Product Code | MSY |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-29 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858293006106 | K132344 | 000 |