The following data is part of a premarket notification filed by Jerome Medical with the FDA for J Tongs.
| Device ID | K930021 |
| 510k Number | K930021 |
| Device Name: | J TONGS |
| Classification | Tong, Skull For Traction |
| Applicant | JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Contact | Daniel L Clemens |
| Correspondent | Daniel L Clemens JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-05 |
| Decision Date | 1995-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977308718 | K930021 | 000 |
| 05690977308701 | K930021 | 000 |
| 05690977197305 | K930021 | 000 |
| 05690977197299 | K930021 | 000 |
| 05690977197282 | K930021 | 000 |
| 05690977197275 | K930021 | 000 |
| 05690977193123 | K930021 | 000 |