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510(k) K841171

TRILICON BREASE PROSTHESIS DIFFERENT by Baurs Krey Assoc., Inc. — Product Code GBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
March 19, 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 Baurs Krey Assoc., Inc.

  • K841252 — GLATTELAST COMPRESSION PANTY HOSE (June 27, 1984)
  • K841215 — GLATTELAST COMPRESSION STOCKINGS (June 7, 1984)
  • K841253 — COMPRESSION STOCKINGS W/WAIST SUSPENS- (March 26, 1984)

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)
  • K841559 — CONFORMA (July 17, 1984)
  • K832151 — PDM SILOXANE PROSTHETIC ORBIT (December 19, 1983)