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510(k) K770359

IMPLANTING OF POLYACRYLIC FIBERS by Allan V. Marse — Product Code GBI

K770359 is an FDA 510(k) premarket notification submitted by Allan V. Marse for the device "IMPLANTING OF POLYACRYLIC FIBERS". The FDA issued a decision of Substantially Equivalent on April 8, 1977. The device falls under product code GBI (Material, External Aesthetic Restoration, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1977
Date Received
February 22, 1977
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 for product code GBI

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  • 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)

FDA data resources