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510(k) K893380

Device
QCR SYSTEM I AND QCR SYSTEM II
Applicant
BREMER MFG. & TOOL CO., INC.
510(k) number
K893380
Product code
LGH  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-16
Date received
1989-05-01
Regulation
888.5960
Classification name
Instrument, Cast Removal, Ac-powered
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
EDWARD LIVINGSTON
Address
1455 W Fairbanks Ave. Post Office Box 2894 Winter Park FL US 32790 32790

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LGH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932653SWISSTEK 2000(TM) CAST REMOVAL SYSTEMCarapace, Inc.1994-01-28
K901677CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTERBuckman Co., Inc.1990-04-23
K895861DELTA-TECH(TM) CAST REMOVAL SYSTEMJohnson & Johnson Professionals, Inc.1989-10-19
K873723PLASTER VACUUM, 230V MODEL NO. 4183-161Martin Medical1987-12-10
K873721PLASTER VACUUM, 115V MODEL NO. 4183-160Martin Medical1987-12-07
K873719CAST CUTTER, 115V MODEL NO. 4183-106Martin Medical1987-10-02
K873720CAST CUTTER, 230V MODEL NO. 4183-107Martin Medical1987-10-02
K820351CAST CUTTER/CAST SAW/INSTRUMENTBlack & Decker(Tm)1982-03-02

Legacy Summary#

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FDA Review#

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