The following data is part of a premarket notification filed by Reckitt Benckiser, Inc. with the FDA for Sporox Ii Sterilizing & Disinfecting Solution.
| Device ID | K990703 |
| 510k Number | K990703 |
| Device Name: | SPOROX II STERILIZING & DISINFECTING SOLUTION |
| Classification | Sterilant, Medical Devices |
| Applicant | RECKITT BENCKISER, INC. 1655 VALLEY RD. Wayne, NJ 07474 |
| Contact | Sean Mcnear |
| Correspondent | Sean Mcnear RECKITT BENCKISER, INC. 1655 VALLEY RD. Wayne, NJ 07474 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-04 |
| Decision Date | 1999-03-30 |
| Summary: | summary |