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510(k) K812401

Device
CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O
Applicant
SURGICAL APPLIANCE INDUSTRIES, INC.
510(k) number
K812401
Product code
IPT  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-14
Date received
1981-08-20
Regulation
890.3490
Classification name
Orthosis, Thoracic
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963091VOLLMAN PRONE POSITIONERHill-Rom, Inc.1997-01-09
K821645BACK SKPPORTSFred Sammons, Inc.1982-06-11
K811750MULTITUBULAR THORACIC AIR SPLINTSRoger Cestac & Assoc.1981-07-20
K761128LATERAL TRUNK SUPPORTSFred Sammons, Inc.1976-12-02

Legacy Summary#

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FDA Review#

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