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510(k) K801633

THE BRAVO NEW PARALLEL FLOW DIALYZER by Bellco Artifidial Organ Spec., Inc. — Product Code FJG

K801633 is an FDA 510(k) premarket notification submitted by Bellco Artifidial Organ Spec., Inc. for the device "THE BRAVO NEW PARALLEL FLOW DIALYZER". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Bellco Artifidial Organ Spec., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
July 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Bellco Artifidial Organ Spec., Inc.

  • K801634 — THE VITA 2 DISPOSABLE DIALYZER (December 17, 1980)
  • K801632 — THE BELLCO FISTULA NEEDLES (August 4, 1980)

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (September 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (August 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (August 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (September 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (January 8, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
  • K812336 — COBE PPD 1.9 (August 31, 1981)

FDA data resources