SILIMED BREAST FORM— 510(k) K842765

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K842765 for SILIMED BREAST FORM, Substantially Equivalent on 1984-08-17. Applicant: Sil-Med Corp.. Device class: 1.

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1984-07-16
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBI

K880329 — FACTOR II PROSTHETIC SILICONE ELASTOMER1988-06-01
K874279 — AHH NATURAL BREAST FORM1987-10-29
K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY1987-07-21
K864785 — AMOENA BREAST FORMS1987-01-08
K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT1987-01-08

More clearances from Sil-Med Corp.

K972521 — NAVIGATOR (STYLET) 20061997-10-01
K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II1997-07-18
K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN1996-08-08
K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR1996-06-26
K960099 — PENROSE DRAIN MODELS 6001 - 60071996-03-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.