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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 K884043
Device Name GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
Applicant
GRIESHABER & CO.
3000 CABOT BLVD. WEST
P.O. BOX 1099
LANGHORNE,  PA  19047
Applicant Contact JOHN E RICHMOND
Correspondent
GRIESHABER & CO.
3000 CABOT BLVD. WEST
P.O. BOX 1099
LANGHORNE,  PA  19047
Correspondent Contact JOHN E RICHMOND
Regulation Number886.4150
Classification Product Code
HQE  
Date Received09/26/1988
Decision Date 11/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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