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510(k) K842765

SILIMED BREAST FORM by Sil-Med Corp. — Product Code GBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
July 16, 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 Sil-Med Corp.

  • K972521 — NAVIGATOR (STYLET) 2006 (October 1, 1997)
  • K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II (July 18, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (June 26, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K955463 — GRIP-A-BOOTS (January 23, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K926496 — SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (May 24, 1995)
  • K926495 — SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (February 2, 1994)
  • K926408 — SIL-SLIP FLAT SUCTION DRAIN (February 2, 1994)

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)
  • K841559 — CONFORMA (July 17, 1984)
  • K841171 — TRILICON BREASE PROSTHESIS DIFFERENT (April 25, 1984)
  • K832151 — PDM SILOXANE PROSTHETIC ORBIT (December 19, 1983)