SPEMBLY 9000 & 9300— 510(k) K802063

Substantially Equivalent

Spembly Medical , Ltd.

FDA 510(k) clearance K802063 for SPEMBLY 9000 & 9300, Substantially Equivalent on 1980-10-03. Applicant: Spembly Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Spembly Medical , Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1980-08-26
Decision date: 1980-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spembly Medical , Ltd.

K925129 — SELECTOR1993-04-23
K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES1990-10-11
K901974 — SELECTOR ULTRASONIC SURGICAL ASPIRATOR1990-09-05
K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY1988-09-27
K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)1988-08-08

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