The following data is part of a premarket notification filed by Ossur Americans (formerly The Jerome Group) with the FDA for Resolve Tongs, Small/medium, Resolve Tongs, Medium/large, Model Jt-200d, Jt-100d.
| Device ID | K071173 |
| 510k Number | K071173 |
| Device Name: | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D |
| Classification | Tong, Skull For Traction |
| Applicant | OSSUR AMERICANS (FORMERLY THE JEROME GROUP) 1414 METROPOLITAN AVENUE Paulsboro, NJ 08066 |
| Contact | Bernie Tatro |
| Correspondent | Bernie Tatro OSSUR AMERICANS (FORMERLY THE JEROME GROUP) 1414 METROPOLITAN AVENUE Paulsboro, NJ 08066 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-27 |
| Decision Date | 2007-05-25 |
| Summary: | summary |