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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K813389
Device Name ULTRASONIC FRAGMENTOR
Applicant
Fibra Sonics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Fibra Sonics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4150
Classification Product Code
HQE  
Date Received12/03/1981
Decision Date 02/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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