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510(k) K951701

Device
FMS ARTHRO-CUTTER
Applicant
FUTURE MEDICAL SYSTEMS, INC.
510(k) number
K951701
Product code
HNX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-09
Date received
1995-04-12
Regulation
886.4350
Classification name
Depressor, Orbital
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PATRICK JANIN
Address
205 E. 63rd St. Suite 7a New York City NY US 10021 10021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951702FMS HIGH FLOW ARTHRO-SHEATHFuture Medical Systems, Inc.1995-05-12

Legacy Summary#

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FDA Review#

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