FDA 510(k) Application Details - K973110

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K973110
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant LUDLOW TECHNICAL PRODUCTS
TWO LUDLOW PARK
P.O. BOX 297
CHICOPEE, MA 01021-0297 US
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Contact PATRICK A MALIA
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 08/20/1997
Decision Date 10/21/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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