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510(k) K862524

Device
DEKNATEL (R) TREPHINE
Applicant
DEKNATEL, INC.
510(k) number
K862524
Product code
HRH  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-11
Date received
1986-07-02
Regulation
886.4350
Classification name
Trephine, Manual, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
OROFINO
Address
2300 Marcus Ave. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022843GAYHEART CORNEAL EXCISION DEVICEStephens Instruments2002-11-01
K931792ARTHROSCOPEIntramed Laboratories, Inc.1994-06-13
K873918HEAD & CHIN RESTSRichmond Products, Inc.1987-10-28
K864520BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRONPrecision Instruments, Inc.1987-01-20
K861825CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADEStorz Instrument Co.1986-06-09
K860648BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIAPrecision Instruments, Inc.1986-03-25
K843646STEINWAY MICRO-KERATO-TREPHINESteinway Instrument Co., Inc.1985-01-03
K843048RING SUPPORTED TREPHINE FOR CORNEA TRANSPrecision Instruments, Inc.1984-10-05
K812723PEARCE CORNEAL TREPHINEVisitec Co.1981-10-13
K781411CORNEAL CUTTER AND ACCESSORIESCodman & Shurtleff, Inc.1978-09-20
K771866TROUTMAN CORNEAL PUNCHEdward Weck, Inc.1977-11-09

Legacy Summary#

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FDA Review#

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