TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS
FDA 510(k) clearance K951703 · decided 1995-06-28
Clearance details
- K-number
- K951703
- Device name
- TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS
- Applicant
- Products For Medicine
- Decision
- Substantially Equivalent
- Date received
- 1995-04-12
- Decision date
- 1995-06-28
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LRT
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (K002937) | Albert Browne , Ltd. | 2001-11-05 |
| TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (K965154) | Albert Browne , Ltd. | 1997-09-19 |
| CROSS-CHECKS (K951113) | Steritec Products Mfg Co, Inc. | 1996-08-19 |
| STERILIZATION INDICATOR FOR FLASH STERILIZATION (K871672) | Propper Mfg. Co., Inc. | 1987-06-01 |
Recalls involving this device
No recalls on record reference this clearance.