HOPPENSTEIN MICROSURGICAL SPINAL INSTRU

Curette, Surgical, General Use

DOWNS SURGICAL LTD.

The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Hoppenstein Microsurgical Spinal Instru.

Pre-market Notification Details

Device IDK842701
510k NumberK842701
Device Name:HOPPENSTEIN MICROSURGICAL SPINAL INSTRU
ClassificationCurette, Surgical, General Use
Applicant DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFZS  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-11
Decision Date1984-08-02

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