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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K854751
Device Name ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
Applicant
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Applicant Contact JOHNSON
Correspondent
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Correspondent Contact JOHNSON
Regulation Number874.4350
Classification Product Code
EQH  
Date Received11/26/1985
Decision Date 02/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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