FDA 510(k) Application Details - K944947

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K944947
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BOSTON SURGICAL PRODUCTS, INC.
203 INDIAN POND RD.
KINGSTON, MA US
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Contact LAWRENCE T KIRWAN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/07/1994
Decision Date 07/28/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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