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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Corneal
510(k) Number K844409
Device Name DTL ELECTRODE
Applicant
Sauquoit Industries, Inc.
P.O. Box 1279, 300 Palm
St.
Scranton,  PA  18501
Applicant Contact JOHN SCOFIELD
Correspondent
Sauquoit Industries, Inc.
P.O. Box 1279, 300 Palm
St.
Scranton,  PA  18501
Correspondent Contact JOHN SCOFIELD
Regulation Number886.1220
Classification Product Code
HLZ  
Date Received11/14/1984
Decision Date 02/14/1985
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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