The following data is part of a premarket notification filed by Applied Medical Systems with the FDA for #cto 100 (cervical Traction Orthosis 100).
| Device ID | K861470 |
| 510k Number | K861470 |
| Device Name: | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) |
| Classification | Tong, Skull For Traction |
| Applicant | APPLIED MEDICAL SYSTEMS 727 NORTH 19TH ST. Allentown, PA 18104 |
| Contact | Jack M Potts |
| Correspondent | Jack M Potts APPLIED MEDICAL SYSTEMS 727 NORTH 19TH ST. Allentown, PA 18104 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-22 |
| Decision Date | 1986-05-02 |