The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Speculite.
Device ID | K963391 |
510k Number | K963391 |
Device Name: | SPECULITE |
Classification | Source, Chemiluminescent Light |
Applicant | TRYLON CORP. 23268 ATLANTIS WAY Monarch Beach, CA 92629 |
Contact | A. Thomas Doyle |
Correspondent | A. Thomas Doyle TRYLON CORP. 23268 ATLANTIS WAY Monarch Beach, CA 92629 |
Product Code | MPU |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-28 |
Decision Date | 1997-12-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPECULITE 73558251 1403895 Dead/Cancelled |
TRYLON ASSOCIATES, LTD. 1985-09-12 |