STERRAD 100 STERILIZATION SYSTEM
FDA 510(k) clearance K915682 · decided 1993-10-01
Clearance details
- K-number
- K915682
- Device name
- STERRAD 100 STERILIZATION SYSTEM
- Applicant
- Johnson & Johnson Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-19
- Decision date
- 1993-10-01
- Days to decision
- 652 days
- Clearance type
- Traditional
- Product code
- FLF
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
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| TSO3 OZONE STERILIZER, MODEL 125L (K090636) | Tso3, Inc. | 2009-12-02 |
| TSO3 OZONE STERILIZER, MODEL 125L (K051595) | Tso3, Inc. | 2006-07-26 |
| TSO3 OZONE STERILIZER, MODEL 125L (K020875) | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 |
| H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (K014013) | H & W Technology, LLC | 2003-06-25 |
| STERRAD 50 & STERRAD 100S STERILIZERS (K023290) | Advanced Sterilization Products | 2003-04-03 |
| ABTOX PLAZLYTE PROCESS MONITOR (K923442) | Abtox, Inc. | 1994-12-22 |
| PLAZLYTE(TM) (K905119) | Abtox, Inc. | 1994-12-22 |
| STERI-VAC GAS STERILIZER MODEL 8XL (K941748) | 3M Health Care, Ltd. | 1994-12-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-SORB ABSORBABLE DUSTING POWDER (N6264/S003) | Johnson & Johnson Medical, Inc. | 1985-09-10 |