The following data is part of a premarket notification filed by Alba Health Care with the FDA for Alba Health Care Plain Packing Strip.
| Device ID | K861154 |
| 510k Number | K861154 |
| Device Name: | ALBA HEALTH CARE PLAIN PACKING STRIP |
| Classification | Gauze/sponge, Internal |
| Applicant | ALBA HEALTH CARE POST OFFICE BOX 100 Valdese, NC 28690 |
| Contact | Victor H Garrou |
| Correspondent | Victor H Garrou ALBA HEALTH CARE POST OFFICE BOX 100 Valdese, NC 28690 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-28 |
| Decision Date | 1986-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 01065973017256 | K861154 | 000 |
| 10665973017249 | K861154 | 000 |
| 10665973017232 | K861154 | 000 |
| 10665973017225 | K861154 | 000 |
| 00665973017259 | K861154 | 000 |