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 |