The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Overtube For Endscopic Ligator.
| Device ID | K924764 |
| 510k Number | K924764 |
| Device Name: | OVERTUBE FOR ENDSCOPIC LIGATOR |
| Classification | Endoscopic Bite Block |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Maureen G Mccabe |
| Correspondent | Maureen G Mccabe SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | MNK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-23 |
| Decision Date | 1993-03-15 |