Product code FME— General Hospital

FDA has cleared 5 devices under product code FME between 1976 and 1988, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19881 clearance
• 19811 clearance
• 19771 clearance
• 19762 clearances

• Precept, Inc.1 clearance
• Kimberly-Clark Corp.1 clearance
• Graham Manufacturing Co.1 clearance
• General Medical Co.1 clearance
• American Hospital Supply Corp.1 clearance

• K880385 — KIMBERLY-CLARK PROFESSIONAL JACKETKimberly-Clark Corp.·1988-02-19
• K811915 — MONITOR/VITAL SIGNS TRAYAmerican Hospital Supply Corp.·1981-07-28
• K770476 — EXAM GOWNGeneral Medical Co.·1977-05-06
• K760954 — CROWNTEX EXAM. CAPE & GOWNGraham Manufacturing Co.·1976-12-30
• K760360 — SHIRT, MITTEN CUFF INFANTPrecept, Inc.·1976-10-20