Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K970924
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K970924
Device Name
Surgeon'S Gloves
Applicant
REGENT MEDICAL
2926 COLUMBIA HIGHWAY
PO BOX 8308
DOTHAN, AL 36304 US
Other 510(k) Applications for this Company
Contact
NEIL ANDERSON
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
03/07/1997
Decision Date
04/01/1997
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