510(k) K171639

Trojan Supra Lubricated Polyurethane Male Condom by Church & Dwight Co., Inc. — Product Code MOL

K171639 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "Trojan Supra Lubricated Polyurethane Male Condom". The FDA issued a decision of Substantially Equivalent on August 1, 2017. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2017
Date Received
June 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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