510(k) K080420
- Device
- RESERT XL HLD HIGH LEVEL DISINFECTANT
- Applicant
- STERIS Corporation
- 510(k) number
- K080420
- Product code
- MED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-02
- Date received
- 2008-02-15
- Regulation
- 880.6885
- Classification name
- Sterilant, Medical Devices
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN R SCOVILLE JR.
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3005763425
- 2518897
- 1410097
- 2029275
- 1941138
- 3013188547
- 3010166945
- 1319130
- 2013736
- 3001239013
- 1720499
- 1450386
- 3030447506
- 3005698329
- 3011632
- 2424472
- 1833387
- 3038718579
- 3012809732
- 3015392401
- 1221361
- 2242327
- 3007663067
- 3003950207
- 1722021
- 3008114965
- 1527821
- 2183301
- 2084725
- 2515379
- 3034286426
- 9680353
- 2150060
- 2028411
- 1933443
- 3000251274
- 1937531
Source Documents#
Other 510(k) Records For Product Code MED #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2026-04-08 |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation | 2023-10-03 |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2023-03-28 |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | 2022-09-28 |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | 2021-09-07 |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | 2021-05-12 |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2019-12-10 |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | 2019-09-05 |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | Steris Corporations | 2019-03-22 |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | 2019-01-31 |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | 2018-04-04 |
| K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | 2018-03-02 |
| K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2017-09-22 |
| K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2016-08-05 |
| K140703 | OPA 30 SOLUTION | Ciden Technologies, LLC | 2014-08-19 |
Legacy Summary#
summary
FDA Review#
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