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510(k) K013707

SOFTIQUE, MODEL GI 11001 by Global TV Concepts, Ltd. — Product Code IMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2002
Date Received
November 8, 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 Global TV Concepts, Ltd.

  • K973179 — FEMINIQUE SONIC HAIR REMOVER (October 30, 1997)
  • K973174 — SONIQUE HAIR REMOVER (October 30, 1997)

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  • K022626 — MOISTURESTAY (REVLON) (October 29, 2002)
  • K013328 — REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 (December 3, 2001)
  • 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)