FDA 510(k) Application Details - K182054

Device Classification Name Expander, Skin, Inflatable

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510(K) Number K182054
Device Name Expander, Skin, Inflatable
Applicant Allergan
2525 Dupont Drive
Irvine, CA 92612 US
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Contact Melissa Pathmajeyan
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Regulation Number 000.0000

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Classification Product Code LCJ
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Date Received 07/31/2018
Decision Date 08/29/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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