Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K001049
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K001049
Device Name
Surgeon'S Gloves
Applicant
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2000
Decision Date
05/23/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact