The following data is part of a premarket notification filed by Safety Syringes, Inc. with the FDA for Modification To: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (x-series).
| Device ID | K060743 |
| 510k Number | K060743 |
| Device Name: | MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) |
| Classification | Syringe, Antistick |
| Applicant | SAFETY SYRINGES, INC. 1939 PALOMAR OAKS WAY, SUITE A Carlsbad, CA 92009 |
| Contact | Thomas L Hall |
| Correspondent | Thomas L Hall SAFETY SYRINGES, INC. 1939 PALOMAR OAKS WAY, SUITE A Carlsbad, CA 92009 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-04-28 |
| Summary: | summary |