The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Touriquet Kit With Snare.
Device ID | K855144 |
510k Number | K855144 |
Device Name: | TOURIQUET KIT WITH SNARE |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
Contact | Ronald A William |
Correspondent | Ronald A William DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-26 |
Decision Date | 1986-02-05 |