The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Verres Needle.
Device ID | K942484 |
510k Number | K942484 |
Device Name: | VERRES NEEDLE |
Classification | Pneumoperitoneum Needle |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
Contact | Carol A Weideman, Ph.d. |
Correspondent | Carol A Weideman, Ph.d. LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
Product Code | FHO |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-25 |
Decision Date | 1994-06-24 |