FDA 510(k) Application Details - K971758

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K971758
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant APPLIED MEDICAL TECHNOLOGIES
15653 NEO PKWY.
CLEVELAND, OH 44128-3150 US
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Contact THOMAS W PARKINSON
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/13/1997
Decision Date 07/21/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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