Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K990332
Device Classification Name
Gauze, External (With Drug/Biologic/Animal Source Material)
More FDA Info for this Device
510(K) Number
K990332
Device Name
Gauze, External (With Drug/Biologic/Animal Source Material)
Applicant
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO M1S 3S4 CA
Other 510(k) Applications for this Company
Contact
SHARMINI ATHERAY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
GER
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/03/1999
Decision Date
04/14/1999
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact