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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 K801176
Device Name FIBER OPTIC LIGHT SOURCE
Applicant
ASPEN LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ASPEN LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4350
Classification Product Code
EQH  
Date Received05/16/1980
Decision Date 05/28/1980
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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