Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071754
Device Classification Name
Dilator, Vaginal
More FDA Info for this Device
510(K) Number
K071754
Device Name
Dilator, Vaginal
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
Other 510(k) Applications for this Company
Contact
CRYSTAL DIZOL
Other 510(k) Applications for this Contact
Regulation Number
884.3900
More FDA Info for this Regulation Number
Classification Product Code
HDX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/2007
Decision Date
01/07/2009
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