The following data is part of a premarket notification filed by Doc's Proplugs, Inc. with the FDA for Doc's Proplugs Ear Plugs.
Device ID | K945376 |
510k Number | K945376 |
Device Name: | DOC'S PROPLUGS EAR PLUGS |
Classification | Protector, Hearing (insert) |
Applicant | DOC'S PROPLUGS, INC. 416 LIGHTHOUSE AVE. Santa Cruz, CA 95060 |
Contact | Robert T Scott |
Correspondent | Robert T Scott DOC'S PROPLUGS, INC. 416 LIGHTHOUSE AVE. Santa Cruz, CA 95060 |
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 | 1994-10-21 |
Decision Date | 1995-11-14 |