The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Endoscopic Elastic Band Ligator.
| Device ID | K880648 |
| 510k Number | K880648 |
| Device Name: | ENDOSCOPIC ELASTIC BAND LIGATOR |
| Classification | Ligator, Hemorrhoidal |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Paul Bernard |
| Correspondent | Paul Bernard SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-17 |
| Decision Date | 1988-04-06 |