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510(k) K854241

Device
AOT EXTERNAL COMPRESS DEVICE
Applicant
ADVANCED ORTHO-TECHNOLOGY, INC.
510(k) number
K854241
Product code
HWN  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-03
Date received
1985-10-21
Regulation
888.4540
Classification name
Instrument, Compression
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALLEN P SCHLEIN
Address
150 Marbledale Rd. Tuckahoe NY US 10707 10707

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792253ARICULATED TENSION DEVICE SYNTHES TENSynthes (Usa)1979-12-05
K770349RIGID TEACHING ATTACHMENTRichard Wolf Medical Instruments Corp.1977-03-07
K760970FLORIO CPC BANDRichard'S Medical Equip., Inc.1976-11-23

Legacy Summary#

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FDA Review#

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