FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CURASORB ZN ALGINATE WOUND DRESSING

K Number: K950775 · Decision Apr 3, 1995
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
66
Review Days
41

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
CURASORB ZN ALGINATE WOUND DRESSING
K Number
K950775
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.5090
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
Date Received
February 21, 1995
Decision Date
April 3, 1995
Product Code
KMF
Advisory Committee
General Hospital
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KMF Bandage, Liquid

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KMF), ordered by most recent decision date.

View all

Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

K Number Device Name
K973763 KENDALL CURITY IODOFORM PACKING STRIP
K973511 KENDALL CURITY PETROLATUM GAUZE
K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973619 KENDALL CURITY NON-ADHERING DRESSING
K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
K963446 KENDALL DUAL LUMEN CATHETER
K964899 KENDALL CURITY URETERAL CATHETER
K964519 CURITY THORACENTESIS TRAY
Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →