The following data is part of a premarket notification filed by Adven Medical with the FDA for Reprocessed Disposable Trocars.
Device ID | K013987 |
510k Number | K013987 |
Device Name: | REPROCESSED DISPOSABLE TROCARS |
Classification | Trocar, Sinus |
Applicant | ADVEN MEDICAL 1001 SLATON HWY. Lubbock, TX 79404 |
Contact | Mark W Aldana |
Correspondent | Mark W Aldana ADVEN MEDICAL 1001 SLATON HWY. Lubbock, TX 79404 |
Product Code | KBG |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-04 |
Decision Date | 2002-03-01 |
Summary: | summary |