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510(k) K893380

QCR SYSTEM I AND QCR SYSTEM II by Bremer Mfg. & Tool Co., Inc. — Product Code LGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1989
Date Received
May 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cast Removal, Ac-Powered
Device Class
Class I
Regulation Number
888.5960
Review Panel
OR
Submission Type

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  • K873719 — CAST CUTTER, 115V MODEL NO. 4183-106 (October 2, 1987)
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  • K820351 — CAST CUTTER/CAST SAW/INSTRUMENT (March 2, 1982)