510(k) K951113
- Device
- CROSS-CHECKS
- Applicant
- STERITEC PRODUCTS MFG. CO., INC.
- 510(k) number
- K951113
- Product code
- LRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-19
- Date received
- 1995-03-10
- Regulation
- 880.2800
- Classification name
- Indicator, Sterilization
- 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
- TOM ROLL
- Address
- 680 Atchison Way, Suite #600 Castle Rock CO US 80104 80104
FDA Registration Numbers#
- 2410251
- 2028456
Source Documents#
Other 510(k) Records For Product Code LRT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Albert Browne , Ltd. | 2001-11-05 |
| K965154 | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Albert Browne , Ltd. | 1997-09-19 |
| K951703 | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | Products For Medicine | 1995-06-28 |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Propper Mfg. Co., Inc. | 1987-06-01 |
Legacy Summary#
summary
FDA Review#
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