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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K840429
Device Name SUN-LITE ONE MILLIMETER
Applicant
Suncoast Medical Manufacturers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Suncoast Medical Manufacturers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received01/31/1984
Decision Date 04/13/1984
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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