The following data is part of a premarket notification filed by Mednext, Inc. with the FDA for Triton Hudson Chuck Attachment.
Device ID | K983092 |
510k Number | K983092 |
Device Name: | TRITON HUDSON CHUCK ATTACHMENT |
Classification | Motor, Drill, Pneumatic |
Applicant | MEDNEXT, INC. 5490 DEXTER WAY West Palm Beach, FL 33407 |
Contact | Stewart Willason |
Correspondent | Stewart Willason MEDNEXT, INC. 5490 DEXTER WAY West Palm Beach, FL 33407 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-03 |
Decision Date | 1998-11-06 |