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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 K844570
Device Name QUANTUM 412
Applicant
Keta Corp.
9 Canal St.
Danvers,  MA  01923
Applicant Contact KENNETH P TAYLOR
Correspondent
Keta Corp.
9 Canal St.
Danvers,  MA  01923
Correspondent Contact KENNETH P TAYLOR
Regulation Number886.1605
Classification Product Code
HPT  
Date Received11/23/1984
Decision Date 12/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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