Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K162162
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K162162
Device Name
Wrap, Sterilization
Applicant
Standard Textile Co., Inc.
One Knollcrest Drive
Cincinnati, OH 45237 US
Other 510(k) Applications for this Company
Contact
Bradley J. Bushman
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2016
Decision Date
11/04/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
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