FDA.report

510(k) K981756

Device
SHELHIGH NO-REACT PNEUMOPLEDGETS
Applicant
SHELHIGH, INC.
510(k) number
K981756
Product code
FTL  
Decision
Substantially Equivalent (SESE)
Decision date
1998-08-05
Date received
1998-05-18
Regulation
878.3300
Classification name
Mesh, Surgical, Polymeric
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
67-71 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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