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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861028
Device Name SUPERLITE PENLIGHT
Applicant
Keta Corp.
9 Canal St.
Danvers,  MA  01923
Applicant Contact KENNETH TAYLOR
Correspondent
Keta Corp.
9 Canal St.
Danvers,  MA  01923
Correspondent Contact KENNETH TAYLOR
Date Received03/18/1986
Decision Date 04/04/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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