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510(k) K960621

Device
EXPANDACELL INSTRUMENT WIPE
Applicant
SHIPPERT MEDICAL TECHNOLOGIES CORP.
510(k) number
K960621
Product code
GER  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-01
Date received
1996-02-13
Regulation
510(k) Premarket Notification
Classification name
Gauze, External (with Drug/biologic/animal Source Material)
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SARAH MAXWELL LAKE
Address
7002 S. Revere Pkwy. Suite 60 Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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