The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Acco(r) Face Mask.
| Device ID | K880613 |
| 510k Number | K880613 |
| Device Name: | ACCO(R) FACE MASK |
| Classification | Mask, Surgical |
| Applicant | ABSORBENT COTTON CO., INC. P.O. BOX 268 368 FAIRVIEW AVENUE Hammonton, NJ 08037 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb ABSORBENT COTTON CO., INC. P.O. BOX 268 368 FAIRVIEW AVENUE Hammonton, NJ 08037 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-16 |
| Decision Date | 1988-03-04 |