The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Table Accessories, Operating Room.
Device ID | K852332 |
510k Number | K852332 |
Device Name: | TABLE ACCESSORIES, OPERATING ROOM |
Classification | Table And Attachments, Operating-room |
Applicant | SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
Contact | Jacobus Scholten |
Correspondent | Jacobus Scholten SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City, CA 94063 |
Product Code | BWN |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-31 |
Decision Date | 1985-07-02 |