Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K220455 |
Device Name |
Lap-Band System Calibration Tube |
Applicant |
ReShape Lifesciences |
1001 Calle Amanecer |
San Clemente,
CA
92673
|
|
Applicant Contact |
Michelle Ravert |
Correspondent |
ReShape Lifesciences |
1001 Calle Amanecer |
San Clemente,
CA
92673
|
|
Correspondent Contact |
Michelle Ravert |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/17/2022 |
Decision Date | 06/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|