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510(k) K013328

REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 by Remington Products Company, LLC — Product Code IMC

K013328 is an FDA 510(k) premarket notification submitted by Remington Products Company, LLC for the device "REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600". The FDA issued a decision of Substantially Equivalent on December 3, 2001. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Remington Products Company, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2001
Date Received
October 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Paraffin
Device Class
Class II
Regulation Number
890.5110
Review Panel
PM
Submission Type

Other clearances by Remington Products Company, LLC

  • K895410 — REMINGTON TANFASTIC HANDHELD TANNING WAND (November 27, 1989)
  • K895409 — REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER (October 20, 1989)

Other clearances for product code IMC

  • K093100 — REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) (November 24, 2009)
  • K022626 — MOISTURESTAY (REVLON) (October 29, 2002)
  • K013707 — SOFTIQUE, MODEL GI 11001 (February 1, 2002)
  • K001860 — PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA (August 10, 2000)
  • K991427 — PARAMED PARAFFIN WARMER (August 13, 1999)
  • K980718 — PARA-CARE (March 27, 1998)
  • K861344 — R1124 & R1686 PARAFFIN (May 27, 1986)
  • K861346 — R1363 PARAFFIN (May 2, 1986)
  • K842423 — PARA THERM BATH (June 28, 1984)
  • K833631 — THERMAMED BATH (November 28, 1983)

FDA data resources