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510(k) K842423

PARA THERM BATH by Grimm Scientific Industries, Inc. — Product Code IMC

K842423 is an FDA 510(k) premarket notification submitted by Grimm Scientific Industries, Inc. for the device "PARA THERM BATH". The FDA issued a decision of Substantially Equivalent on June 28, 1984. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Grimm Scientific Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1984
Date Received
June 20, 1984
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 Grimm Scientific Industries, Inc.

  • K951769 — CRYOPRESS (October 16, 1995)
  • K864721 — CRYOTHERM (February 4, 1987)

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)
  • 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)
  • K833631 — THERMAMED BATH (November 28, 1983)

FDA data resources