The following data is part of a premarket notification filed by Plastic Engineered Products Co. with the FDA for Sofswab.
| Device ID | K871879 |
| 510k Number | K871879 |
| Device Name: | SOFSWAB |
| Classification | Toothbrush, Manual |
| Applicant | PLASTIC ENGINEERED PRODUCTS CO. 800 SAVANNAH AVENUE N.E. Canton, OH 44704 |
| Contact | Charles P Thompson |
| Correspondent | Charles P Thompson PLASTIC ENGINEERED PRODUCTS CO. 800 SAVANNAH AVENUE N.E. Canton, OH 44704 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-14 |
| Decision Date | 1987-07-28 |