EQUIP COVERS, STERILE— 510(k) K897120

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K897120 for EQUIP COVERS, STERILE, Substantially Equivalent on 1990-01-04. Applicant: Amedic USA. Device class: 2.

Clearance details

Applicant: Amedic USA
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1989-12-26
Decision date: 1990-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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More clearances from Amedic USA

K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE1989-09-05
K892069 — EXTENDED COVERS, STERILE1989-08-08
K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE1989-08-08
K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE1989-08-04
K871467 — BIOPSY NEEDLE GUIDE KIT, STERILE1987-08-21

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