STRYKER 2115 REPLACEMENT BATTERY (2115)— 510(k) K970378

Name: FDA 510(k) clearance K970378
Creator: U.S. Food and Drug Administration
Published: 1997-04-30

Substantially Equivalent

Implant Resource, Inc.

FDA 510(k) clearance K970378 for STRYKER 2115 REPLACEMENT BATTERY (2115), Substantially Equivalent on 1997-04-30. Applicant: Implant Resource, Inc.. Device class: 1.

Clearance details

Applicant: Implant Resource, Inc.
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1997-01-31
Decision date: 1997-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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