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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K810300
Device Name FIBER OPTIC ADAPTERS#60-0893
Applicant
Aspen Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Aspen Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4580
Classification Product Code
HBI  
Date Received02/03/1981
Decision Date 02/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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