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510(k) K963091

Device
VOLLMAN PRONE POSITIONER
Applicant
HILL-ROM, INC.
510(k) number
K963091
Product code
IPT  
Decision
Substantially Equivalent (SESE)
Decision date
1997-01-09
Date received
1996-08-08
Regulation
890.3490
Classification name
Orthosis, Thoracic
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWIN L BILLS
Address
4349 Corporate Rd. Charleston SC US 29405 29405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821645BACK SKPPORTSFred Sammons, Inc.1982-06-11
K812401CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. OSurgical Appliance Industries, Inc.1981-09-14
K811750MULTITUBULAR THORACIC AIR SPLINTSRoger Cestac & Assoc.1981-07-20
K761128LATERAL TRUNK SUPPORTSFred Sammons, Inc.1976-12-02

Legacy Summary#

summary

FDA Review#

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