The following data is part of a premarket notification filed by Emerald Medical, Inc. with the FDA for Emerald Medical, Inc. Nucleus Pulposis Evacuator System.
| Device ID | K964919 |
| 510k Number | K964919 |
| Device Name: | EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM |
| Classification | Arthroscope |
| Applicant | EMERALD MEDICAL, INC. MILL LN. RD. Brimfield, MA 01010 |
| Contact | Joseph S Mooney |
| Correspondent | Joseph S Mooney EMERALD MEDICAL, INC. MILL LN. RD. Brimfield, MA 01010 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-01-28 |
| Summary: | summary |