The following data is part of a premarket notification filed by Disco, Inc. with the FDA for Quicklamp System.
Device ID | K923085 |
510k Number | K923085 |
Device Name: | QUICKLAMP SYSTEM |
Classification | Clamp, Vascular |
Applicant | DISCO, INC. 1860 WILLAMETTE DR. West Linn, OR 97068 |
Contact | Bryon G Zahler |
Correspondent | Bryon G Zahler DISCO, INC. 1860 WILLAMETTE DR. West Linn, OR 97068 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1993-02-12 |