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510(k) K903001

Device
SLIMCATH (TM)
Applicant
GYNOPHARMA, INC.
510(k) number
K903001
Product code
HIT  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-25
Date received
1990-07-09
Regulation
886.1170
Classification name
Tester, Color Vision
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEVI ELLIS
Address
C/O Ellis Pharm Consulting Inc 913 State Rd. Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875026ANOMALOSCOPE PLATE TEST - 5 [APT-5]Lkc Technologies, Inc.1988-02-05
K873908H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.Richmond Products, Inc.1987-12-23
K873911PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15Richmond Products, Inc.1987-12-02
K844694TITMUS VISION TESTER IITitmus Optical, Inc.1985-01-22
K844365COLOR VISION TESTERSLuneau Laboratories1985-01-02
K832843OSCAR COLOUR VISION TESTERKeeler Instruments, Inc.1984-01-04
K831074OSCAR COLOR VISION TESTERCarl Zeiss, Inc.1983-04-28
K810700CHROMOPS FM-100 COLOR VISION TESTERVisidyne Corp.1981-04-10

Legacy Summary#

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FDA Review#

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