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FDA 510(k) Application Details - K190788
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K190788
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati, OH 45242 US
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Contact
Alison Sathe
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/27/2019
Decision Date
04/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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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