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510(k) K863664

Device
OPHTHALMIC SURGICAL SPECULUM
Applicant
MYOCURE, INC.
510(k) number
K863664
Product code
HNC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-25
Date received
1986-09-18
Regulation
886.4350
Classification name
Specula, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALEXA C JENSEN
Address
1736 Flower St. Glendale CA US 91201 91201

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022836STEPHENS DISPOSABLE SPECULUMStephens Instruments2002-11-01
K981235OCULOSTATLaser Center Dev. Corp.1998-07-15
K964289EYE FIXATION SPECULUMEyefix, Inc.1996-12-17
K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.1986-10-31
K843196VISITEC EYE SPECULUMVisitec Co.1984-10-05
K830430EYELID SPECULUMDouglas C. Mckee & Co.1983-06-10
K801969ASNIS GUIDED SCREW SYSTEMSHowmedica Corp.1980-08-27
K760847FELDSTEIN BLEPHAROPLASTY CLIP SHARP PV. Mueller O.V. Baxter Healthcare Corp.1976-11-02
K760848FELDSTEIN BLEPHAROPLASTY CLIP RECTANGUV. Mueller O.V. Baxter Healthcare Corp.1976-11-02
K760849FELDSTEIN BLEPHAROSTOMY CLIP SQUAREV. Mueller O.V. Baxter Healthcare Corp.1976-11-02

Legacy Summary#

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FDA Review#

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