510(k) K833515

BOUINS SOLUTION by Sigma Chemical Co. — Product Code IGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
October 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Bouin'S
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type