Tamper Evident Arrows with and Without Sterilization Indicators
FDA 510(k) K951703 · Products For Medicine
510(k) numberK951703
Submission
- Device name
- Tamper Evident Arrows with and Without Sterilization Indicators
- Applicant
- Products For Medicine
Irvine, CA, US - Received
- April 12, 1995
- Decision date
- June 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRT – Indicator, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code LRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K002937 | TST Control Integrator for Steam SterilizersLRT · Traditional | Albert Browne , Ltd. | 11/05/2001SE |
| K965154 | TST Control Integrator for Steam AutoclaveLRT · Traditional | Albert Browne , Ltd. | 09/19/1997SE |
| K951113 | Cross-ChecksLRT · Traditional | Steritec Products Mfg Co, Inc. | 08/19/1996SE |
| K871672 | Sterilization Indicator for Flash SterilizationLRT · Traditional | Propper Mfg. Co., Inc. | 06/01/1987SE |
More from Propper Mfg. Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963227 | White Sun Light Source Model #: XL300 and #: XL175GCT · Traditional | 10/23/1996SE |
| K955510 | X6000D Silent Sun Light SourceFST · Traditional | 01/31/1996SE |
| K953089 | I-SpouseLYU · Traditional | 10/16/1995SE |
| K951704 | Non-Woven Filter Paper for Steam and Gas SterilizationFRG · Traditional | 06/28/1995SE |
| K883658 | I-Spose Eye ShieldFXX · Traditional | 10/25/1988SE |
Questions and answers
When was Tamper Evident Arrows with and Without Sterilization Indicators cleared by the FDA?
Tamper Evident Arrows with and Without Sterilization Indicators (K951703) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 77 days after the submission was received.
What is the product code of K951703?
The FDA product code is LRT – Indicator, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.2800.