The following data is part of a premarket notification filed by Blood Products Specialties Llc with the FDA for 30 Ml Or 60 Ml Pedi-syringe Filter.
| Device ID | K050805 |
| 510k Number | K050805 |
| Device Name: | 30 ML OR 60 ML PEDI-SYRINGE FILTER |
| Classification | Set, Blood Transfusion |
| Applicant | BLOOD PRODUCTS SPECIALTIES LLC 184 SEIFFERT COURT Oceanside, NY 11572 |
| Contact | Alan A Waldman |
| Correspondent | Alan A Waldman BLOOD PRODUCTS SPECIALTIES LLC 184 SEIFFERT COURT Oceanside, NY 11572 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-30 |
| Decision Date | 2005-06-20 |
| Summary: | summary |