The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Speculite.
Device ID | K953364 |
510k Number | K953364 |
Device Name: | SPECULITE |
Classification | Laparoscope, Gynecologic (and Accessories) |
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 | HET |
Subsequent Product Code | HEX |
Subsequent Product Code | KZF |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-17 |
Decision Date | 1995-12-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPECULITE 73558251 1403895 Dead/Cancelled |
TRYLON ASSOCIATES, LTD. 1985-09-12 |