TABLE ACCESSORIES, OPERATING ROOM

Table And Attachments, Operating-room

SCHOLTEN SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Table Accessories, Operating Room.

Pre-market Notification Details

Device IDK852332
510k NumberK852332
Device Name:TABLE ACCESSORIES, OPERATING ROOM
ClassificationTable And Attachments, Operating-room
Applicant SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City,  CA  94063
ContactJacobus Scholten
CorrespondentJacobus Scholten
SCHOLTEN SURGICAL INSTRUMENTS, INC. 707 WARRINGTON AVE. Redwood City,  CA  94063
Product CodeBWN  
CFR Regulation Number878.4950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-31
Decision Date1985-07-02

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