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510(k) K981003

ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES by International Medical Products, Inc. — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1998
Date Received
March 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by International Medical Products, Inc.

  • K981069 — ULTRA-COVER PU-TRANSDUCER COVER (September 23, 1998)
  • K973253 — ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (October 30, 1997)
  • K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE D (June 16, 1997)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K900755 — DIGITAL CUFF PV GAUGE (April 26, 1990)
  • K864984 — ROBINJECT (June 29, 1987)
  • K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (February 25, 1987)
  • K861539 — NIKKISO INFUSION PUMP MODEL PFA-02 (July 31, 1986)

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  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)