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510(k) K042648

Device
REPROCESSED COLD BIOPSY FORCEPS
Applicant
STERILMED, INC.
510(k) number
K042648
Product code
NON  
Decision
Substantially Equivalent (SESE)
Decision date
2005-07-20
Date received
2004-09-28
Regulation
876.1075
Classification name
Forceps, Biopsy, Non-electric, Reprocessed
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BRUCE LESTER
Address
11400 73rd Ave. N Maple Grove MN US 55369 55369

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NON  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042659MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPSMedisiss2005-02-14
K042594VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPSVanguard Medical Concepts, Inc.2005-01-25

Legacy Summary#

summary

FDA Review#

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