FDA 510(k) Application Details - K971728

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K971728
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855-0627 US
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Contact BURNS SEVERSON
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/09/1997
Decision Date 09/19/1997
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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