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510(k) K955777

Device
PMMA CLASIC
Applicant
RAND SCIENTIFIC CORP.
510(k) number
K955777
Product code
HPX  
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-16
Date received
1995-12-20
Regulation
510(k) Premarket Notification
Classification name
Lens, Contact (polymethylmethacrylate)
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Ophthalmic
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DUANE TRACY
Address
4135 Northgate Blvd. Suite 9 Sacramento CA US 95834 95834

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HPX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.1994-05-25
K913081MULTI-VIEW BIFOCALSCamp Contact Lenses1991-10-23
K897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward Hensley1990-06-22
K895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.1990-02-27
K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.1988-05-03
K865111CHARTER HARD CONTACT LENS CLEANING SOLUTIONPaco Pharmaceutical Services, Inc.1987-01-20
K864343BL1 (HARD CONTACT LENS)Beta Labs, Inc.1986-11-28
K863974CHARTER LABORATORIES INC. LENS LUBRICANTPaco Pharmaceutical Services, Inc.1986-11-10
K862952CHARTER WETTING SOLUTION FOR HARD CONTACT LENSESPaco Pharmaceutical Services, Inc.1986-09-25
K862811AQUALUX LENS CASESafeway Products, Inc.1986-09-03
K861643STYLEKEEPER CONTACT LENS CARRYING CASEAllergan, Inc.1986-06-02
K860677EASY EYES TM LENS CARRYING CASEApplied Laboratories, Inc.1986-05-29
K861642LENSKEEPER CONTACT LENS CARRYING CASEAllergan, Inc.1986-05-29
K861712WETTING & SOAKING HARD CONTACT LENS SOLUTIONMaurry Biological Co.1986-05-29
K854968BAUSCH & LOMB LENS CARRYING CASEBausch & Lomb, Inc.1986-04-04

Legacy Summary#

summary

FDA Review#

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