Product code FJH— Gastroenterology, Urology

FDA has cleared 4 devices under product code FJH between 1982 and 1992, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19921 clearance
• 19861 clearance
• 19851 clearance
• 19821 clearance

• Travenol Laboratories, S.A.1 clearance
• Trans-National Trade Development Corp.1 clearance
• Societe D' Analyses Bio-Pharmaceutiques,Inc.1 clearance
• National Medical Care, Medical Products Div., Inc.1 clearance

• K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMPNational Medical Care, Medical Products Div., Inc.·1992-09-21
• K861646 — BIO-CARB D16000, D16001, AND D17000Societe D' Analyses Bio-Pharmaceutiques,Inc.·1986-08-07
• K852764 — IDECAP DIALYZERTrans-National Trade Development Corp.·1985-09-20
• K822395 — CF 1211 CAPILLARY FLOW DIALYZER CODETravenol Laboratories, S.A.·1982-08-12