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510(k) K874279

AHH NATURAL BREAST FORM by Pacific Prosthetics, Inc. — Product Code GBI

K874279 is an FDA 510(k) premarket notification submitted by Pacific Prosthetics, Inc. for the device "AHH NATURAL BREAST FORM". The FDA issued a decision of Substantially Equivalent on October 29, 1987. 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
October 29, 1987
Date Received
October 20, 1987
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

  • K880329 — FACTOR II PROSTHETIC SILICONE ELASTOMER (June 1, 1988)
  • 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