The following data is part of a premarket notification filed by Celanese Acetate Co. with the FDA for Joan Ii.
| Device ID | K982648 |
| 510k Number | K982648 |
| Device Name: | JOAN II |
| Classification | Gauze/sponge, Internal |
| Applicant | CELANESE ACETATE CO. PO BOX 32414 Charlotte, NC 28232 -2414 |
| Contact | William C Thomas |
| Correspondent | William C Thomas CELANESE ACETATE CO. PO BOX 32414 Charlotte, NC 28232 -2414 |
| 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 | 1998-07-29 |
| Decision Date | 1998-09-30 |