The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Solace Post-operative Pain Relief Infusion System.
| Device ID | K060933 |
| 510k Number | K060933 |
| Device Name: | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Contact | Whitney Williams |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-05 |
| Decision Date | 2006-05-09 |
| Summary: | summary |