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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name perimeter, automatic, ac-powered
510(k) Number K873122
Device Name TKS 4000 AUTO PERIMETER
Applicant
VISMED, INC.
7920 SILVERTON
SUITE I
SAN DIEGO,  CA  92126
Applicant Contact DALE A RORABAUGH
Correspondent
VISMED, INC.
7920 SILVERTON
SUITE I
SAN DIEGO,  CA  92126
Correspondent Contact DALE A RORABAUGH
Regulation Number886.1605
Classification Product Code
HPT  
Date Received08/10/1987
Decision Date 11/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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