The following data is part of a premarket notification filed by Edgewater Medical Center with the FDA for Edge Medical Dispensing Pin.
| Device ID | K921031 |
| 510k Number | K921031 |
| Device Name: | EDGE MEDICAL DISPENSING PIN |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | EDGEWATER MEDICAL CENTER 9814 CURWOOD PLACE Beverly Hills, CA 90210 |
| Contact | George Loo |
| Correspondent | George Loo EDGEWATER MEDICAL CENTER 9814 CURWOOD PLACE Beverly Hills, CA 90210 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854989006061 | K921031 | 000 |
| 00854989006030 | K921031 | 000 |
| 00854989006023 | K921031 | 000 |