510(k) K902324

TP AND DESIGN, CONDOM by China National Medicines & Health Prod. I/E Corp. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
May 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type