The following data is part of a premarket notification filed by The Jerome Group, Inc. with the FDA for Jerome Glass Ring.
| Device ID | K023959 |
| 510k Number | K023959 |
| Device Name: | JEROME GLASS RING |
| Classification | Tong, Skull For Traction |
| Applicant | THE JEROME GROUP, INC. 305 HARPER DR. Moorestown, NJ 08057 |
| Contact | Bernie Tatro |
| Correspondent | Bernie Tatro THE JEROME GROUP, INC. 305 HARPER DR. Moorestown, NJ 08057 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-27 |
| Decision Date | 2003-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977309357 | K023959 | 000 |
| 05690977164116 | K023959 | 000 |
| 05690977164130 | K023959 | 000 |
| 05690977305885 | K023959 | 000 |
| 05690977305892 | K023959 | 000 |
| 05690977305908 | K023959 | 000 |
| 05690977308596 | K023959 | 000 |
| 05690977309333 | K023959 | 000 |
| 05690977309340 | K023959 | 000 |
| 05690977164093 | K023959 | 000 |