Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071491
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K071491
Device Name
Drape, Surgical
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING, PA 19605 US
Other 510(k) Applications for this Company
Contact
KARL J NITTINGER
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/30/2007
Decision Date
10/10/2007
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