510(k) K965154
- Device
- TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
- Applicant
- ALBERT BROWNE LTD.
- 510(k) number
- K965154
- Product code
- LRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-19
- Date received
- 1996-12-23
- 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
- Expedited review
- Y
Applicant Contact#
- Contact
- CYNTHIA J.M. NOLTE, PH.D.
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
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 |
| K951113 | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | 1996-08-19 |
| 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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