FDA 510(k) Application Details - K191166

Device Classification Name	More FDA Info for this Device
510(K) Number	K191166
Device Name	DigniCap Delta
Applicant	Dignitana Inc. 10925 Estate Lane, Suite W-185 Dallas, TX 75238 US Other 510(k) Applications for this Company
Contact	William Cronin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2019
Decision Date	06/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review