Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062438
Device Classification Name
Instrument, Manual, Specialized Obstetric-Gynecologic
More FDA Info for this Device
510(K) Number
K062438
Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant
COOK OB/GYN
1100 WEST MORGAN STREET
SPENCER, IN 47460 US
Other 510(k) Applications for this Company
Contact
CINDY RUMPLE
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
KNA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2006
Decision Date
10/27/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact