The following data is part of a premarket notification filed by Products For Medicine with the FDA for Tamper Evident Arrows With And Without Sterilization Indicators.
| Device ID | K951703 |
| 510k Number | K951703 |
| Device Name: | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS |
| Classification | Indicator, Sterilization |
| Applicant | PRODUCTS FOR MEDICINE 3722 AVE. SAUSALITO Irvine, CA 92714 |
| Contact | Greg Holland |
| Correspondent | Greg Holland PRODUCTS FOR MEDICINE 3722 AVE. SAUSALITO Irvine, CA 92714 |
| Product Code | LRT |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-12 |
| Decision Date | 1995-06-28 |