The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Dual Radiation Targeting System Drts Drape.
Device ID | K973162 |
510k Number | K973162 |
Device Name: | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE |
Classification | Monitor, Patient Position, Light-beam |
Applicant | HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Product Code | IWE |
CFR Regulation Number | 892.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-22 |
Decision Date | 1997-11-20 |
Summary: | summary |