FDA.report

510(k) K991567

Device
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
Applicant
SHELHIGH, INC.
510(k) number
K991567
Product code
FTM  
Decision
Substantially Equivalent (SESE)
Decision date
1999-07-14
Date received
1999-05-05
Regulation
878.3300
Classification name
Mesh, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
SHLOMO GABBAY
Address
67 E. Willow St. Millburn NJ US 07041 07041

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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