Home / 510(k) Clearances / K832151

510(k) K832151

PDM SILOXANE PROSTHETIC ORBIT by Delaware Prosthetics, Inc. — Product Code GBI

K832151 is an FDA 510(k) premarket notification submitted by Delaware Prosthetics, Inc. for the device "PDM SILOXANE PROSTHETIC ORBIT". The FDA issued a decision of Substantially Equivalent on December 19, 1983. The device falls under product code GBI (Material, External Aesthetic Restoration, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Delaware Prosthetics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1983
Date Received
July 5, 1983
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 Delaware Prosthetics, Inc.

  • K832153 — PDM SILOXANE PROSTHETIC NOSE (December 9, 1983)
  • K832152 — PDM SILOXANE PROSTHETIC EAR (December 9, 1983)
  • K832148 — PDM SILOXANE PROSTHETIC CHIN IMPLANT (November 28, 1983)
  • K832149 — PDM SILOXANE PROSTHETIC OBTURATOR (November 28, 1983)

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)
  • K841171 — TRILICON BREASE PROSTHESIS DIFFERENT (April 25, 1984)

FDA data resources