The following data is part of a premarket notification filed by Flents Products Co., Inc. with the FDA for Seal-rite Silicone Ear Plug.
| Device ID | K910177 |
| 510k Number | K910177 |
| Device Name: | SEAL-RITE SILICONE EAR PLUG |
| Classification | Protector, Hearing (insert) |
| Applicant | FLENTS PRODUCTS CO., INC. P.O. BOX 2109 Norwalk, CT 06852 |
| Contact | Stuart M Low |
| Correspondent | Stuart M Low FLENTS PRODUCTS CO., INC. P.O. BOX 2109 Norwalk, CT 06852 |
| Product Code | EWD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-06-24 |