The following data is part of a premarket notification filed by Interview Medical Technology Corp. with the FDA for Super Siliplugs Ear Plugs.
Device ID | K972923 |
510k Number | K972923 |
Device Name: | SUPER SILIPLUGS EAR PLUGS |
Classification | Protector, Hearing (insert) |
Applicant | INTERVIEW MEDICAL TECHNOLOGY CORP. 3941 PARK DR., SUITE 20-325 El Dorado Hills, CA 95762 |
Contact | Lou Matson |
Correspondent | Lou Matson INTERVIEW MEDICAL TECHNOLOGY CORP. 3941 PARK DR., SUITE 20-325 El Dorado Hills, CA 95762 |
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 | 1997-08-08 |
Decision Date | 1997-10-27 |