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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 -3936
Applicant Contact JOHNSON
Correspondent
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
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
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