The following data is part of a premarket notification filed by Rand Scientific Corp. with the FDA for The Nautilus.
Device ID | K961124 |
510k Number | K961124 |
Device Name: | THE NAUTILUS |
Classification | Prosthesis, Nose, Internal |
Applicant | RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
Contact | Duane Tracy |
Correspondent | Duane Tracy RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
Product Code | FZE |
CFR Regulation Number | 878.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-21 |
Decision Date | 1996-04-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THE NAUTILUS 73438358 not registered Dead/Abandoned |
AMERICAN MALACOLOGISTS, INC. 1983-08-08 |