Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K972104
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K972104
Device Name
Vinyl Patient Examination Glove
Applicant
SHINEMOUND ENTERPRISE, INC.
34 LINNELL CIRCLE
BILLERICA, MA 01821 US
Other 510(k) Applications for this Company
Contact
HUAN-CHUNG LI
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
06/04/1997
Decision Date
08/15/1997
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact