The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Sibis Self Injurious Behavior Inhibiting System.
| Device ID | K853178 |
| 510k Number | K853178 |
| Device Name: | SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM |
| Classification | Device, Aversive Conditioning |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | John K Laurie |
| Correspondent | John K Laurie OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | HCB |
| CFR Regulation Number | 882.5235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1986-02-28 |