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510(k) K990355

Device
STAINLESS STEEL SOFT SUTURE WIRE
Applicant
BREGMA INTERNATIONAL TRADING COMPANY LTD.
510(k) number
K990355
Product code
LRN  
Decision
Substantially Equivalent (SESE)
Decision date
1999-07-08
Date received
1999-02-05
Regulation
888.3030
Classification name
Wire, Surgical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ASSEM HEDAYAT
Address
214-111 Research Dr. Saskatoon, Saskatchewan CA S7N 3R2 S7N 3R2

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K002755NON-ABSORBING STERNATOMY MONOFILAMENT SUTURET. Korossurgical Instruments Corp.2000-12-04
K971682J-FX CERCLAGE SYSTEMJohnson & Johnson Professionals, Inc.1997-06-27
K952783OXBORO-MEDICAL PIN COVERSOxboro Medical Intl., Inc.1995-09-15
K942603ORTHOPAEDIC WIRESAcu Med, Inc.1994-11-09
K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)Howmedica Corp.1990-04-23
K892651SONGER WIRING SYSTEMDanek Medical, Inc.1989-07-25
K864375TYPE 316L COTTER WIREWinn Hirsch & Assoc.1987-05-20

Legacy Summary#

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FDA Review#

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