LUMIN

Cannula, Manipulator/injector, Uterine

UTAH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Lumin.

Pre-market Notification Details

• Device ID: K943448
• 510k Number: K943448
• Device Name: LUMIN
• Classification: Cannula, Manipulator/injector, Uterine
• Applicant: UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048
• Contact: Gail Billings
• Correspondent: Gail Billings; UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048
• Product Code: LKF
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-18
• Decision Date: 1995-04-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H671MIS1000	K943448	000