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FDA 510(k) Application Details - K180451
Device Classification Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
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510(K) Number
K180451
Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe, AZ 85283 US
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Contact
Scott English
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Regulation Number
878.4400
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Classification Product Code
NUJ
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More FDA Info for this Product Code
Date Received
02/20/2018
Decision Date
04/20/2018
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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