The following data is part of a premarket notification filed by R-med, Inc. with the FDA for Riza Band Stretcher (rbs)-60000.
| Device ID | K001236 |
| 510k Number | K001236 |
| Device Name: | RIZA BAND STRETCHER (RBS)-60000 |
| Classification | Ligator, Hemorrhoidal |
| Applicant | R-MED, INC. 3465 NAVARRE AVE., BOX 167636 Oregon, OH 43616 -7636 |
| Contact | Erol D Riza |
| Correspondent | Erol D Riza R-MED, INC. 3465 NAVARRE AVE., BOX 167636 Oregon, OH 43616 -7636 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-18 |
| Decision Date | 2000-07-17 |