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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K914585
Device Name GRIESHABER TWO FUNCTION MANIPULATOR
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 Number874.4350
Classification Product Code
EQH  
Date Received10/16/1991
Decision Date 01/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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