Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K954648
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K954648
Device Name
Hysteroscope (And Accessories)
Applicant
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE, CA 94089 US
Other 510(k) Applications for this Company
Contact
MICHAEL A DANIEL
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/10/1995
Decision Date
03/14/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact