Home / 510(k) Clearances / K852764

510(k) K852764

IDECAP DIALYZER by Trans-National Trade Development Corp. — Product Code FJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1985
Date Received
June 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Disposable
Device Class
Class II
Regulation Number
876.5830
Review Panel
GU
Submission Type

Other clearances by Trans-National Trade Development Corp.

  • K864451 — UV VISIBLE SPECTROPHOTOMETERS (February 6, 1987)

Other clearances for product code FJH

  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K861646 — BIO-CARB D16000, D16001, AND D17000 (August 7, 1986)
  • K822395 — CF 1211 CAPILLARY FLOW DIALYZER CODE (August 12, 1982)