510(k) K201067

CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) by Cupid Limited — Product Code HIS

K201067 is an FDA 510(k) premarket notification submitted by Cupid Limited for the device "CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))". The FDA issued a decision of Substantially Equivalent on Aug 7, 2020. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 7, 2020
Date Received
Apr 22, 2020
Clearance Type
Abbreviated
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
510(k)