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510(k) K872714

S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY by Roseburg SA — Product Code GBI

K872714 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY". The FDA issued a decision of Substantially Equivalent on July 21, 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. Roseburg SA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
July 10, 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 by Roseburg SA

  • K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE (September 1, 1994)
  • K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES (March 9, 1989)
  • K885275 — ASSENAT-BLESCHET SUNGLASSES (January 24, 1989)
  • K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES (August 26, 1988)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR (November 17, 1987)
  • K871688 — SPECTACLE FRAME - DANIELLE (May 29, 1987)
  • K871689 — SPECTACLE FRAME - LORRAINE (May 29, 1987)
  • K870654 — EFER ARTHROSCOPE (May 14, 1987)
  • K864436 — STAVIP 3000 (March 16, 1987)

Other clearances for product code GBI

  • K880329 — FACTOR II PROSTHETIC SILICONE ELASTOMER (June 1, 1988)
  • K874279 — AHH NATURAL BREAST FORM (October 29, 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