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510(k) K900098

Device
MONOPOLAR NEEDLE ELECTRODE
Applicant
OCULINUM, INC.
510(k) number
K900098
Product code
HLW  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-09
Date received
1990-01-08
Regulation
886.1640
Classification name
Preamplifier, Battery-powered, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SCOTT, M.D.
Address
901 Grayson St. Berkeley CA US 94710 94710

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HLW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K900279OCULINUM INJECTION AMPLIFIEROculinum, Inc.1990-02-09
K854793MONOPOLAR INJECTION NEEDLE ELECTRODEOculinum, Inc.1986-02-18

Legacy Summary#

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FDA Review#

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