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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 K982984
Device Name ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
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 Received08/26/1998
Decision Date 10/21/1998
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
Predetermined Change
Control Plan Authorized		 No
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