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510(k) K883408

NATURALYTE MIXER by National Medical Care, Medical Products Div., Inc. — Product Code FIN

K883408 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "NATURALYTE MIXER". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
August 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by National Medical Care, Medical Products Div., Inc.

  • K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET (November 1, 1996)
  • K941757 — FORMALIN REUSE CART (January 22, 1996)
  • K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (December 22, 1995)
  • K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (August 31, 1994)
  • K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (March 5, 1993)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)

Other clearances for product code FIN

  • K140984 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (January 12, 2015)
  • K141213 — AMERIWATER OZONE DISINFECTION SYSTEM (December 10, 2014)
  • K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM (January 26, 2012)
  • K093641 — TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (December 8, 2010)
  • K060333 — DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (September 8, 2006)
  • K051031 — AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (January 6, 2006)
  • K031502 — USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (August 27, 2004)
  • K033118 — BIPRO MODEL SDS-CB200 (June 28, 2004)
  • K030366 — BICARD MIXING SYSTEM (April 19, 2004)
  • K023011 — OSMONICS SOLUTION DELIVERY SYSTEM (June 26, 2003)

FDA data resources