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510(k) K934258

Device
SALINE WET DRESSING- STERILE
Applicant
TRINITY LABORATORIES, INC.
510(k) number
K934258
Product code
GER  
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-24
Date received
1993-08-31
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
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PARTHA BASUMALLIK
Address
201 Kiley Dr. Salisbury MD US 21801 21801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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