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510(k) K932653

Device
SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
Applicant
CARAPACE, INC.
510(k) number
K932653
Product code
LGH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-28
Date received
1993-06-02
Regulation
888.5960
Classification name
Instrument, Cast Removal, Ac-powered
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JERRY W MYERS
Address
2701 W Concord St. Broken Arrow OK US 74012 74012

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
K901677CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTERBuckman Co., Inc.1990-04-23
K893380QCR SYSTEM I AND QCR SYSTEM IIBremer Mfg. & Tool Co., Inc.1989-11-16
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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