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510(k) K803275

KPP PERITONEAL DIALYSATE FILTER by Millipore Corp. — Product Code KPP

K803275 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "KPP PERITONEAL DIALYSATE FILTER". The FDA issued a decision of Substantially Equivalent on March 13, 1981. The device falls under product code KPP (Peritoneal Dialysate Filter), a Class II device regulated under 21 CFR 876.5630. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1981
Date Received
December 29, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peritoneal Dialysate Filter
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Millipore Corp.

  • K023892 — MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (January 17, 2003)
  • K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (April 4, 2002)
  • K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (June 10, 1997)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)
  • K924347 — WATERS(TM) 996 PDA (December 11, 1992)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)

Other clearances for product code KPP

  • K812615 — TM-CAPD (January 5, 1982)
  • K800666 — QUIK-TEMP (May 8, 1980)

FDA data resources