The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Sierra.
Device ID | K924723 |
510k Number | K924723 |
Device Name: | CADWELL SIERRA |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
Contact | Calton M Cadwell |
Correspondent | Calton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-21 |
Decision Date | 1993-03-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CADWELL SIERRA 74371345 not registered Dead/Abandoned |
Cadwell Industries, Inc. 1993-03-24 |