FDA 510(k) Application Details - K030339

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K030339
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ASPEN SURGICAL PRODUCTS, INC.
7425 CLYDE PARK, SUITE G
BYRON CENTER, MI 49315 US
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Contact DEBBIE DALY
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/31/2003
Decision Date 03/07/2003
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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