The following data is part of a premarket notification filed by Stille-werner (usa), Inc. with the FDA for Stille Scandia Operating Tables Rc 3000,1100.
Device ID | K850168 |
510k Number | K850168 |
Device Name: | STILLE SCANDIA OPERATING TABLES RC 3000,1100 |
Classification | Table, Operating-room, Electrical |
Applicant | STILLE-WERNER (USA), INC. 200 THIRTEENTH AVE. Ronkonkoma, NY 11779 |
Contact | Robert W O'donnell |
Correspondent | Robert W O'donnell STILLE-WERNER (USA), INC. 200 THIRTEENTH AVE. Ronkonkoma, NY 11779 |
Product Code | GDC |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-16 |
Decision Date | 1985-03-28 |