The following data is part of a premarket notification filed by Jerome Medical with the FDA for Jms Halo Application Tray.
| Device ID | K864969 |
| 510k Number | K864969 |
| Device Name: | JMS HALO APPLICATION TRAY |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Contact | Suzanne B Beacher |
| Correspondent | Suzanne B Beacher JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977196636 | K864969 | 000 |