The following data is part of a premarket notification filed by Dawn Medical with the FDA for Seroma-cath Close Drainage System.
| Device ID | K905733 |
| 510k Number | K905733 |
| Device Name: | SEROMA-CATH CLOSE DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | DAWN MEDICAL 210 SAN BENITO WAY San Francisco, CA 94127 |
| Contact | Bruce Fitzgerald |
| Correspondent | Bruce Fitzgerald DAWN MEDICAL 210 SAN BENITO WAY San Francisco, CA 94127 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854373007070 | K905733 | 000 |
| 00854373007056 | K905733 | 000 |
| 00854373007025 | K905733 | 000 |
| 00854373007001 | K905733 | 000 |