Atlas FDA

PALL 3N1 FILTER

FDA 510(k) clearance K905794 · decided 1991-06-13

Clearance details

K-number
K905794
Device name
PALL 3N1 FILTER
Applicant
Pall Biomedical Products Co.
Decision
Substantially Equivalent
Date received
1990-12-27
Decision date
1991-06-13
Days to decision
168 days
Clearance type
Traditional
Product code
FPB
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Glen Cove, NY, US
Third-party review
No
Expedited review
No

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I.V. FILTER SET (K933523)Mediziv Medical Products 1987 , Ltd.1995-05-19
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1.2 MICRON AIR ELIMINATING FILTER (K942625)The Medi-Dose Group1994-10-07
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Recalls involving this device

RecordFirmDate
Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low pr recall (Z-2715-2011)Pall Life Sciences Puerto Rico Llc2011-06-30