SGARLATO FLEXIBLE HINGE TOE IMPLANT— 510(k) K905795

Name: FDA 510(k) clearance K905795
Creator: U.S. Food and Drug Administration
Published: 1991-05-29

Substantially Equivalent

Sgarlato Laboratories, Inc.

FDA 510(k) clearance K905795 for SGARLATO FLEXIBLE HINGE TOE IMPLANT, Substantially Equivalent on 1991-05-29. Applicant: Sgarlato Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Sgarlato Laboratories, Inc.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1990-12-27
Decision date: 1991-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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