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510(k) K940480

Device
ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
Applicant
ACUFEX MICROSURGICAL, INC.
510(k) number
K940480
Product code
HTJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-23
Date received
1994-02-02
Regulation
888.4300
Classification name
Gauge, Depth
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LYNNE ARONSON
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 HTJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925335ACUFEX INTRA ARTICULAR MEASURING DEVICEAcufex Microsurgical, Inc.1992-12-29
K873191ACROMED INTERBODY DEPTH GAUGESBuckman Co., Inc.1987-09-09
K864426RAYLOR(TM) DEPTH GAUGECedar Surgical, Inc.1986-11-26

Legacy Summary#

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FDA Review#

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