EXTENDED COVERS, STERILE— 510(k) K892069

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K892069 for EXTENDED COVERS, STERILE, Substantially Equivalent on 1989-08-08. Applicant: Amedic USA. Device class: 1.

Clearance details

Applicant: Amedic USA
Product code: Code FFF
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-31
Decision date: 1989-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

More clearances from Amedic USA

K897120 — EQUIP COVERS, STERILE1990-01-04
K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE1989-09-05
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

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