Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K160361
Device Classification Name
Gown, Isolation, Surgical
More FDA Info for this Device
510(K) Number
K160361
Device Name
Gown, Isolation, Surgical
Applicant
PRIMED MEDICAL PRODUCTS INC.
3RD FLOOR, 1259-91 ST SW.
EDMONTON T6X1E9 CA
Other 510(k) Applications for this Company
Contact
RICHARD R ROY
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/09/2016
Decision Date
11/04/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact