SWELL-RELIEF

Compressor, Cardiac, External

D.A. SCHULMAN, INC.

The following data is part of a premarket notification filed by D.a. Schulman, Inc. with the FDA for Swell-relief.

Pre-market Notification Details

Device IDK855004
510k NumberK855004
Device Name:SWELL-RELIEF
ClassificationCompressor, Cardiac, External
Applicant D.A. SCHULMAN, INC. 7701 NEWTON AVE NORTH Brooklyn Park,  MN  55444
ContactDavid A Schulman
CorrespondentDavid A Schulman
D.A. SCHULMAN, INC. 7701 NEWTON AVE NORTH Brooklyn Park,  MN  55444
Product CodeDRM  
CFR Regulation Number870.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-13
Decision Date1986-02-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.