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510(k) K841559

CONFORMA by Beiersdorf, Inc. — Product Code GBI

K841559 is an FDA 510(k) premarket notification submitted by Beiersdorf, Inc. for the device "CONFORMA". The FDA issued a decision of Substantially Equivalent on July 17, 1984. The device falls under product code GBI (Material, External Aesthetic Restoration, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Beiersdorf, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1984
Date Received
April 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, External Aesthetic Restoration, Used With Adhesive
Device Class
Class I
Regulation Number
878.3800
Review Panel
SU
Submission Type

Other clearances by Beiersdorf, Inc.

  • K090921 — ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, (December 18, 2009)
  • K032462 — CURAD SILVER ACTIVE GEL BANDAGE (February 10, 2004)
  • K032463 — CURAD SILVER BANDAGE (February 10, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K022645 — CURAD (November 5, 2002)
  • K952526 — CUTINOVA CAVITY (August 14, 1995)
  • K943363 — CUTIPLAST STERIL (March 15, 1995)
  • K944581 — CUTINOVA THIN WOUND DRESSING (December 2, 1994)
  • K935630 — NORTA (October 7, 1994)
  • K940378 — COVERLET ADHESIVE DRESSING (July 29, 1994)

Other clearances for product code GBI

  • K880329 — FACTOR II PROSTHETIC SILICONE ELASTOMER (June 1, 1988)
  • K874279 — AHH NATURAL BREAST FORM (October 29, 1987)
  • K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (July 21, 1987)
  • K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (January 8, 1987)
  • K864785 — AMOENA BREAST FORMS (January 8, 1987)
  • K853822 — AMOENA BREAST FORMS (September 30, 1985)
  • K851668 — PROSTHESIS OR SURGICAL PADS (June 4, 1985)
  • K842765 — SILIMED BREAST FORM (August 17, 1984)
  • K841171 — TRILICON BREASE PROSTHESIS DIFFERENT (April 25, 1984)
  • K832151 — PDM SILOXANE PROSTHETIC ORBIT (December 19, 1983)

FDA data resources