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 |