SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY

Tube, Tympanostomy

RICHARD'S MEDICAL EQUIP., INC.

The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Spoon-bobbin Drain Tube W/ Wire, Otology.

Pre-market Notification Details

• Device ID: K760438
• 510k Number: K760438
• Device Name: SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY
• Classification: Tube, Tympanostomy
• Applicant: RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: ETD
• CFR Regulation Number: 874.3880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-08-16
• Decision Date: 1976-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925019713	K760438	000
00821925035065	K760438	000