Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K103220
Device Classification Name
System, Peritoneal, Automatic Delivery
More FDA Info for this Device
510(K) Number
K103220
Device Name
System, Peritoneal, Automatic Delivery
Applicant
DEKA RESEARCH & DEVELOPMENT CORP.
340 COMMERCIAL ST.
MANCHESTER, NH 03101 US
Other 510(k) Applications for this Company
Contact
ROGER A LEROUX
Other 510(k) Applications for this Contact
Regulation Number
876.5630
More FDA Info for this Regulation Number
Classification Product Code
FKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/01/2010
Decision Date
07/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact