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510(k) K850983

Device
MARLIN SOFT LENS TWEEZER
Applicant
MARLIN INDUSTRIES
510(k) number
K850983
Product code
KYE  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-10
Date received
1985-03-11
Regulation
886.5420
Classification name
Inserter/remover Contact Lens
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEROME HIRSCH
Address
P.O. Box 284 Tarzana CA US 91356 91356

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872567SOFT CONTACT LENS REMOVERMagnivision, Inc.1987-08-10
K872591HARD CONTACT LENS REMOVER. ITEM #289Magnivision, Inc.1987-08-04
K871130CONTACT LENS TWEEZERSS. M. C. Medi-Tech Corp.1987-05-12
K870072SUMMIT OPTICS CONTACT LENS REMOVERDayton Mfg. Co.1987-02-12
K850984MARLIN SOFT LENS HANDLERMarlin Industries1985-09-10
K830738LENSERT CONTACT LENS CLEANING & INSERTJermyn Specialties of California1983-06-10
K830496DMV ANGLERDmv Contact Lens Co.1983-03-09
K782140REMOVER, SOFT-SERT CONTACT LENSMcmurray and Pendergost1979-02-12
K780931SOFT LENS INSERTERSoft-Sert1978-06-28
K780663CONTACT LENS REMOVER AND INSERTERDmv Contact Lens Co.1978-05-17
K780664SOFT LENS REMOVER/INSERTER/MANIPULATORDmv Contact Lens Co.1978-05-17

Legacy Summary#

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FDA Review#

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