QCR SYSTEM I AND QCR SYSTEM II— 510(k) K893380

Name: FDA 510(k) clearance K893380
Creator: U.S. Food and Drug Administration
Published: 1989-11-16

Substantially Equivalent

Bremer Mfg. & Tool Co., Inc.

FDA 510(k) clearance K893380 for QCR SYSTEM I AND QCR SYSTEM II, Substantially Equivalent on 1989-11-16. Applicant: Bremer Mfg. & Tool Co., Inc.. Device class: 1.

Clearance details

Applicant: Bremer Mfg. & Tool Co., Inc.
Product code: Code LGH
Device class: Class 1
Regulation: 21 CFR 888.5960
Advisory panel: Orthopedic
Date received: 1989-05-01
Decision date: 1989-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, US

Download summary PDF View on FDA.gov ↗

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