510(k) K951703
- Device
- TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS
- Applicant
- PRODUCTS FOR MEDICINE
- 510(k) number
- K951703
- Product code
- LRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-28
- Date received
- 1995-04-12
- Regulation
- 880.2800
- Classification name
- Indicator, Sterilization
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GREG HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92714 92714
FDA Registration Numbers#
- 2410251
- 2028456
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K951113 | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | 1996-08-19 |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Propper Mfg. Co., Inc. | 1987-06-01 |
Legacy Summary#
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FDA Review#
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