The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Johnson & Johnson Fluff Sponge.
| Device ID | K881222 |
| 510k Number | K881222 |
| Device Name: | JOHNSON & JOHNSON FLUFF SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Omega Norton-crable |
| Correspondent | Omega Norton-crable JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| 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 | 1988-03-22 |
| Decision Date | 1988-03-28 |