Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971797
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K971797
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
LOUISVILLE LABORATORIES, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number
884.1720
More FDA Info for this Regulation Number
Classification Product Code
HET
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/15/1997
Decision Date
07/22/1997
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