Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K980005
Device Classification Name
Bag, Bile Collecting
More FDA Info for this Device
510(K) Number
K980005
Device Name
Bag, Bile Collecting
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
4445 SW 35TH TERRACE
SUITE 310
GAINESVILLE, FL 32608 US
Other 510(k) Applications for this Company
Contact
KARL SWARTZ
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
EXF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/02/1998
Decision Date
01/30/1998
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