RECTAL BALLOON CATHETERS

Tubes, Gastrointestinal (and Accessories)

INMED CORP.

The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Rectal Balloon Catheters.

Pre-market Notification Details

• Device ID: K841036
• 510k Number: K841036
• Device Name: RECTAL BALLOON CATHETERS
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: INMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-03-12
• Decision Date: 1984-04-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704302165	K841036	000
44026704302152	K841036	000