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510(k) K854793

Device
MONOPOLAR INJECTION NEEDLE ELECTRODE
Applicant
OCULINUM, INC.
510(k) number
K854793
Product code
HLW  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1986-02-18
Date received
1985-12-05
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
P. O. Box 175 Mill Valley CA US 94942 94942

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
K900098MONOPOLAR NEEDLE ELECTRODEOculinum, Inc.1990-02-09
K900279OCULINUM INJECTION AMPLIFIEROculinum, Inc.1990-02-09

Legacy Summary#

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FDA Review#

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