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510(k) K880329

FACTOR II PROSTHETIC SILICONE ELASTOMER by Factor, Ii, Inc. — Product Code GBI

K880329 is an FDA 510(k) premarket notification submitted by Factor, Ii, Inc. for the device "FACTOR II PROSTHETIC SILICONE ELASTOMER". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code GBI (Material, External Aesthetic Restoration, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Factor, Ii, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1988
Date Received
January 26, 1988
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 Factor, Ii, Inc.

  • K984297 — MAGNA ABUTMENT (January 28, 2000)
  • K831095 — ROYALE II (August 31, 1983)

Other clearances for product code GBI

  • K874279 — AHH NATURAL BREAST FORM (October 29, 1987)
  • K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (July 21, 1987)
  • K864785 — AMOENA BREAST FORMS (January 8, 1987)
  • K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (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)
  • K841559 — CONFORMA (July 17, 1984)
  • K841171 — TRILICON BREASE PROSTHESIS DIFFERENT (April 25, 1984)
  • K832151 — PDM SILOXANE PROSTHETIC ORBIT (December 19, 1983)

FDA data resources