The following data is part of a premarket notification filed by Advanced Ortho-technology, Inc. with the FDA for Aot External Compress Device.
| Device ID | K854241 |
| 510k Number | K854241 |
| Device Name: | AOT EXTERNAL COMPRESS DEVICE |
| Classification | Instrument, Compression |
| Applicant | ADVANCED ORTHO-TECHNOLOGY, INC. 150 MARBLEDALE RD. Tuckahoe, NY 10707 |
| Contact | Allen P Schlein |
| Correspondent | Allen P Schlein ADVANCED ORTHO-TECHNOLOGY, INC. 150 MARBLEDALE RD. Tuckahoe, NY 10707 |
| Product Code | HWN |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1986-03-03 |