ALPHAMED SURGICAL SPEAR, MODEL 70-5000— 510(k) K091240

Name: FDA 510(k) clearance K091240
Creator: U.S. Food and Drug Administration
Published: 2009-10-23

Substantially Equivalent

Alphamed, Inc.

FDA 510(k) clearance K091240 for ALPHAMED SURGICAL SPEAR, MODEL 70-5000, Substantially Equivalent on 2009-10-23. Applicant: Alphamed, Inc.. Device class: 2.

Clearance details

Applicant: Alphamed, Inc.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 2009-04-27
Decision date: 2009-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, US

Download summary PDF View on FDA.gov ↗

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