Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971061
Device Classification Name
General Surgery Tray
More FDA Info for this Device
510(K) Number
K971061
Device Name
General Surgery Tray
Applicant
OPPORTUNITY, INC.
1200 OLD SKOKIE RD.
HIGHLAND PARK, IL 60035 US
Other 510(k) Applications for this Company
Contact
JAMES S SANDERS
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
LRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/1997
Decision Date
06/11/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact