LESSER METATARSAL PHALANG. JOINT PROSTH— 510(k) K820813

Name: FDA 510(k) clearance K820813
Creator: U.S. Food and Drug Administration
Published: 1982-05-21

Substantially Equivalent

Sutter Biomedical, Inc.

FDA 510(k) clearance K820813 for LESSER METATARSAL PHALANG. JOINT PROSTH, Substantially Equivalent on 1982-05-21. Applicant: Sutter Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Sutter Biomedical, Inc.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1982-03-23
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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