Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K163659
Device Classification Name
Apparatus, Exhaust, Surgical
More FDA Info for this Device
510(K) Number
K163659
Device Name
Apparatus, Exhaust, Surgical
Applicant
I.C MEDICAL, INC.
2340 W. SHANGRI LA RD.
PHOENIX, AZ 85029 US
Other 510(k) Applications for this Company
Contact
ELENA S. BUIGA
Other 510(k) Applications for this Contact
Regulation Number
878.5070
More FDA Info for this Regulation Number
Classification Product Code
FYD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2016
Decision Date
10/30/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact