Reshape Lifesciences

FDA Filings

This page includes the latest FDA filings for Reshape Lifesciences. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013508647
FEI Number3013508647
NameReShape Lifesciences
Owner & OperatorReShape Lifesciences
Contact Address1001 Calle Amanecer
San Clemente CA 92673 US
Official Correspondent
  • Dov Gal
  • x-949-4814789-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1001 Calle Amanecer
San Clemente, CA 92673 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
ReShape Lifesciences
Gastrointestinal Boundary Identifier (GIBI HD)2022-07-28
ReShape Lifesciences
Lap-Band System Calibration Tube2022-06-07
ReShape Lifesciences
Gastric Balloon Suction Catheter2019-02-08
ReShape Lifesciences
LAP-BAND AP System Large with RapidPort EZ Access Port; LAP-BAND AP System Standard with RapidPort EZ Access Port; LAP-B2019-01-30

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