510(k) K951917

JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS by Johnson & Johnson Consumer Products, Inc. — Product Code JES

K951917 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Consumer Products, Inc. for the device "JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS". The FDA issued a decision of Substantially Equivalent on May 10, 1995. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Johnson & Johnson Consumer Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
April 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Floss, Dental
Device Class
Class I
Regulation Number
872.6390
Review Panel
DE
Submission Type