The following data is part of a premarket notification filed by Bentec Medical, Inc. with the FDA for Silicone Putty Ear Plugs.
| Device ID | K971517 |
| 510k Number | K971517 |
| Device Name: | SILICONE PUTTY EAR PLUGS |
| Classification | Protector, Hearing (insert) |
| Applicant | BENTEC MEDICAL, INC. 4234 NORTH FREEWAY BLVD. Sacramento, CA 95834 |
| Contact | Louis R Matson |
| Correspondent | Louis R Matson BENTEC MEDICAL, INC. 4234 NORTH FREEWAY BLVD. Sacramento, CA 95834 |
| 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 | 1997-04-25 |
| Decision Date | 1997-06-02 |