510(k) K840679

SERENITY CONTOURED ABSORBENT SHIELDS by Johnson & Johnson Consumer Products, Inc. — Product Code EYQ

K840679 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Consumer Products, Inc. for the device "SERENITY CONTOURED ABSORBENT SHIELDS". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Johnson & Johnson Consumer Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
February 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Garment, Protective, For Incontinence
Device Class
Class I
Regulation Number
876.5920
Review Panel
GU
Submission Type