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510(k) K960993

PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) by Pall Biomedical Products Co. — Product Code CAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1996
Date Received
March 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Pall Biomedical Products Co.

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  • K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE (October 16, 1990)
  • K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER (January 24, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K873667 — PALL LEUKOCYTE REMOVAL FILTER, PLATELETS (January 6, 1988)
  • K873666 — PALL LEUKOCYTE REMOVAL FILTER, BLOOD (January 6, 1988)
  • K874405 — PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (December 30, 1987)
  • K853987 — PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (December 11, 1985)

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  • K904223 — SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (October 26, 1990)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)