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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 K781471
Device Name PNEUMATIC VITRECTOMY CONTROL UNIT
Applicant
Helfgott Medical Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Helfgott Medical Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/28/1978
Decision Date 11/08/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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