The following data is part of a premarket notification filed by Reshape Lifesciences with the FDA for Lap-band System Calibration Tube.
| Device ID | K220455 |
| 510k Number | K220455 |
| Device Name: | Lap-Band System Calibration Tube |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ReShape Lifesciences 1001 Calle Amanecer San Clemente, CA 92673 |
| Contact | Michelle Ravert |
| Correspondent | Michelle Ravert ReShape Lifesciences 1001 Calle Amanecer San Clemente, CA 92673 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007764173 | K220455 | 000 |