FDA 510(k) Application Details - K183328

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K183328
Device Name	Sleeve, Limb, Compressible
Applicant	NormaTec Industries, LP 480 Pleasant St, Suite A200 Watertown, MA 02472 US Other 510(k) Applications for this Company
Contact	Albert G. Sanford Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2018
Decision Date	12/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review