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FDA 510(k) Application Details - K982218
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K982218
Device Name
Polymer Patient Examination Glove
Applicant
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
PT 7521 TAMAN SEMARAK II
LIGHT INDUSTRIAL PARK
NILAI, NEGERI SEMBILAN 71800 71800 MY
Other 510(k) Applications for this Company
Contact
TARANI DEVI
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/1998
Decision Date
11/30/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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