510(k) K895409

REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER by Remington Products Company, LLC — Product Code LEJ

K895409 is an FDA 510(k) premarket notification submitted by Remington Products Company, LLC for the device "REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER". The FDA issued a decision of Substantially Equivalent on October 20, 1989. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Remington Products Company, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1989
Date Received
September 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Booth, Sun Tan
Device Class
Class II
Regulation Number
878.4635
Review Panel
SU
Submission Type