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FDA 510(k) Application Details - K944676
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K944676
Device Name
Catheter, Retention Type, Balloon
Applicant
MRI MANUFACTURING AND RESEARCH, INC.
2045 NORTH FORBES BLVD.
SUITE 105
TUSCON, AZ 85745 US
Other 510(k) Applications for this Company
Contact
PATRICK J LAMB
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/1994
Decision Date
04/05/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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