The following data is part of a premarket notification filed by Bioplastics with the FDA for Biothane Patient Restraint.
| Device ID | K991591 |
| 510k Number | K991591 |
| Device Name: | BIOTHANE PATIENT RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | BIOPLASTICS 34655 MILLS RD. N. Ridgeville, OH 44039 |
| Contact | Claire Boron |
| Correspondent | Claire Boron BIOPLASTICS 34655 MILLS RD. N. Ridgeville, OH 44039 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-07-29 |