MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

Wound Cleaner, Ultrasound

CELLERATION, INC.

The following data is part of a premarket notification filed by Celleration, Inc. with the FDA for Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case Of 12.

Pre-market Notification Details

• Device ID: K122246
• 510k Number: K122246
• Device Name: MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
• Classification: Wound Cleaner, Ultrasound
• Applicant: CELLERATION, INC. 6321 BURY DRIVE, STE 15 Eden Prairie, MN 55346
• Contact: Kathy Simpson
• Correspondent: Kathy Simpson; CELLERATION, INC. 6321 BURY DRIVE, STE 15 Eden Prairie, MN 55346
• Product Code: NRB
• CFR Regulation Number: 878.4410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-27
• Decision Date: 2012-08-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20816789010246	K122246	000