SHROUDED NEEDLE DEVICES

Set, Administration, Intravascular

IMED CORP.

The following data is part of a premarket notification filed by Imed Corp. with the FDA for Shrouded Needle Devices.

Pre-market Notification Details

• Device ID: K924718
• 510k Number: K924718
• Device Name: SHROUDED NEEDLE DEVICES
• Classification: Set, Administration, Intravascular
• Applicant: IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699
• Contact: Ralph H Jarboe
• Correspondent: Ralph H Jarboe; IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-09-21
• Decision Date: 1993-06-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50885403233461	K924718	000