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510(k) K893380

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

K893380 is an FDA 510(k) premarket notification submitted by Bremer Mfg. & Tool Co., Inc. for the device "QCR SYSTEM I AND QCR SYSTEM II". The FDA issued a decision of Substantially Equivalent on November 16, 1989. The device falls under product code LGH (Instrument, Cast Removal, Ac-Powered), a Class I device regulated under 21 CFR 888.5960.

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

Other clearances for product code LGH

  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K901677 — CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (April 23, 1990)
  • K895861 — DELTA-TECH(TM) CAST REMOVAL SYSTEM (October 19, 1989)
  • K873723 — PLASTER VACUUM, 230V MODEL NO. 4183-161 (December 10, 1987)
  • K873721 — PLASTER VACUUM, 115V MODEL NO. 4183-160 (December 7, 1987)
  • K873719 — CAST CUTTER, 115V MODEL NO. 4183-106 (October 2, 1987)
  • K873720 — CAST CUTTER, 230V MODEL NO. 4183-107 (October 2, 1987)
  • K820351 — CAST CUTTER/CAST SAW/INSTRUMENT (March 2, 1982)

FDA data resources