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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K890782
Device Name GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)
Applicant
Grieshaber & Co.
3000 Cabot Blvd. W.
P.O. Box 1099
Langhorne,  PA  19047
Applicant Contact JOHN E RICHMOND
Correspondent
Grieshaber & Co.
3000 Cabot Blvd. W.
P.O. Box 1099
Langhorne,  PA  19047
Correspondent Contact JOHN E RICHMOND
Regulation Number886.4350
Classification Product Code
HMX  
Date Received02/15/1989
Decision Date 06/23/1989
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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