FDA 510(k) Application Details - K120798

Device Classification Name Vinyl Patient Examination Glove

  More FDA Info for this Device
510(K) Number K120798
Device Name Vinyl Patient Examination Glove
Applicant CANOPUS MEDICAL SUPPLY CO., LTD.
18709 GREEN BAT DR.,
ROWLAND HIGHS, CA 91748 US
Other 510(k) Applications for this Company
Contact GLORIA CHANG
Other 510(k) Applications for this Contact
Regulation Number 880.6250

  More FDA Info for this Regulation Number
Classification Product Code LYZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/15/2012
Decision Date 05/14/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact