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510(k) K923381

Device
SOFT TISSUE EXPANDER
Applicant
ACUFEX MICROSURGICAL, INC.
510(k) number
K923381
Product code
HWQ  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-05
Date received
1992-07-09
Regulation
888.4540
Classification name
Passer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SUSAN GOLDSTEIN-FALK
Address
130 Forbes Blvd. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970360MITEK SUTURE RETROGRADERMitek Products1997-03-10
K920621ACUFEX PASSING PINS AND SURGICAL WIREAcufex Microsurgical, Inc.1993-05-05
K885311MENISCUS MENDER II LOOPInstrument Makar, Inc.1989-02-09
K843592VICO MICRO SURGICAL INSTRUMENTSVisitec Co.1984-10-05
K841622SOFT-TISSUE INSTRUMENTPlastafil, Inc.1984-07-11
K841623SLOTTED SOFT-TISSUE INSTRUMENTPlastafil, Inc.1984-07-11
K811679SILASTIC TENDON PASSER H.P.Dow Corning Corp. Healthcare Industries Materials1981-07-10
K791960ROTH-KENNEDY PASSER3M Company1979-10-04

Legacy Summary#

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FDA Review#

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