Procellera

Dressing, Wound, Drug

VOMARIS INNOVATIONS, INC.

The following data is part of a premarket notification filed by Vomaris Innovations, Inc. with the FDA for Procellera.

Pre-market Notification Details

• Device ID: K160783
• 510k Number: K160783
• Device Name: Procellera
• Classification: Dressing, Wound, Drug
• Applicant: VOMARIS INNOVATIONS, INC. 1911 E. 5TH ST Tempe, AZ 85281
• Contact: Timothy Joiner
• Correspondent: Timothy Joiner; VOMARIS INNOVATIONS, INC. 1911 E. 5TH ST Tempe, AZ 85281
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2016-03-22
• Decision Date: 2016-09-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00894318002647	K160783	000
00810198031577	K160783	000
00810198030013	K160783	000
00810198030327	K160783	000
00810198030358	K160783	000
00810198030372	K160783	000
00810198030389	K160783	000
00894318002579	K160783	000
00894318002586	K160783	000
00894318002593	K160783	000
00894318002609	K160783	000
00894318002616	K160783	000
00894318002623	K160783	000
00894318002630	K160783	000
00810198031560	K160783	000