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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K981389
Device Name DISPOSABLE RE-NEW FORCEPS
Applicant
MICROLINE PENTAX, INC.
70 WALNUT ST.
WELLESLEY,  MA  02481 -2102
Applicant Contact JACQUELINE E MASSE
Correspondent
MICROLINE PENTAX, INC.
70 WALNUT ST.
WELLESLEY,  MA  02481 -2102
Correspondent Contact JACQUELINE E MASSE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/16/1998
Decision Date 05/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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