510(k) K023290
- Device
- STERRAD 50 & STERRAD 100S STERILIZERS
- Applicant
- ADVANCED STERILIZATION PRODUCTS
- 510(k) number
- K023290
- Product code
- FLF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-03
- Date received
- 2002-10-02
- Regulation
- 880.6860
- Classification name
- Sterilizer, Ethylene-oxide Gas
- 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
- NATALIE BENNINGTON
- Address
- 33 Technology Dr. Irvin CA US 92618 92618
FDA Registration Numbers#
- 3005899764
- 3005646850
- 3004634710
- 3031841433
- 3003936696
- 2133641
- 3015392401
- 2084725
- 3042272797
Source Documents#
Other 510(k) Records For Product Code FLF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2020-11-12 |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2017-10-31 |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2015-11-18 |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | 2015-01-08 |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2009-12-02 |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2006-07-26 |
| K020875 | TSO3 OZONE STERILIZER, MODEL 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 |
| K014013 | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | H & W Technology, LLC | 2003-06-25 |
| K923442 | ABTOX PLAZLYTE PROCESS MONITOR | Abtox, Inc. | 1994-12-22 |
| K905119 | PLAZLYTE(TM) | Abtox, Inc. | 1994-12-22 |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | 1994-12-02 |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | American Sterilizer Co. | 1994-02-07 |
| K915682 | STERRAD 100 STERILIZATION SYSTEM | Johnson & Johnson Medical, Inc. | 1993-10-01 |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mdt Corp., Inc. | 1993-03-31 |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | 1991-09-06 |
Legacy Summary#
summary
FDA Review#
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