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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K864056
Device Name GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT
Applicant
Grieshaber & Co.
1056 Trenton Rd.
P.O. Box 807
Fallisington,  PA  19054
Applicant Contact JOHN E RICHMOND
Correspondent
Grieshaber & Co.
1056 Trenton Rd.
P.O. Box 807
Fallisington,  PA  19054
Correspondent Contact JOHN E RICHMOND
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/15/1986
Decision Date 10/31/1986
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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