The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Trocar Sleeve, Sealing Caps, Reducer, Loop Guide.
| Device ID | K942414 |
| 510k Number | K942414 |
| Device Name: | TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1994-06-21 |