FDA 510(k) Application Details - K202554

Device Classification Name Scalpel, Ultrasonic, Reprocessed

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510(K) Number K202554
Device Name Scalpel, Ultrasonic, Reprocessed
Applicant Stryker Sustainability Solutions
1810 W. Drake Dr.
Tempe, AZ 85283 US
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Contact Aphrodeja Crutch
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Regulation Number 000.0000

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Classification Product Code NLQ
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Date Received 09/03/2020
Decision Date 03/16/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K202554


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