Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K960648
Device Classification Name
Paper, Obstetric Ph
More FDA Info for this Device
510(K) Number
K960648
Device Name
Paper, Obstetric Ph
Applicant
FEMTEK, INC.
50 BELLEFONTAINE ST.
PASADENA, CA 91105-3181 US
Other 510(k) Applications for this Company
Contact
JAMES C CAILLOUETTE, MD
Other 510(k) Applications for this Contact
Regulation Number
862.1550
More FDA Info for this Regulation Number
Classification Product Code
LNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/1996
Decision Date
05/13/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
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