The following data is part of a premarket notification filed by Albahealth Products with the FDA for Iodoform Packaging Strip.
| Device ID | K940339 |
| 510k Number | K940339 |
| Device Name: | IODOFORM PACKAGING STRIP |
| Classification | Gauze/sponge, Internal |
| Applicant | ALBAHEALTH PRODUCTS BOX 100 Valdese, NC 28690 |
| Contact | Victor H Garrou |
| Correspondent | Victor H Garrou ALBAHEALTH PRODUCTS 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 | 1994-01-25 |
| Decision Date | 1994-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10665973017218 | K940339 | 000 |
| 10665973017201 | K940339 | 000 |
| 10665973017195 | K940339 | 000 |
| 20665973016515 | K940339 | 000 |