Submission Details
| 510(k) Number | K050805 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 2005 |
| Decision Date | June 20, 2005 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
30 ML OR 60 ML PEDI-SYRINGE FILTER
Jun 2005
Decision
82d
Days
Class 2
Risk
About This 510(k) Submission
K050805 is an FDA 510(k) clearance for the 30 ML OR 60 ML PEDI-SYRINGE FILTER, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Blood Products Specialties, LLC (Oceanside, US). The FDA issued a Cleared decision on June 20, 2005, 82 days after receiving the submission on March 30, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | BRZ — Set, Blood Transfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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