FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING

K Number: K945977 · Decision Mar 29, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
16
Review Days
111

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Basic Information

Device Name
CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING
K Number
K945977
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Tri-State Hospital Supply Corp.
Date Received
December 8, 1994
Decision Date
March 29, 1995
Product Code
MGP
Advisory Committee
Unknown
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
MGP Dressing, Wound And Burn, Occlusive

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Other Clearances by Tri-State Hospital Supply Corp.

K Number Device Name
K080448 CENTURION PROTECTIVE RESTRAINT, SCR SERIES
K080524 CENTURION SORBAVIEW OTC
K942353 CENTURION UMBILICAL CATHETER
K931748 CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
K935491 CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
K923812 CENTURION DISPOSABLE INSTRUMENTS
K910906 CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
K897100 CENTURION VAGINAL SPECULUM
K896320 CENTURION KLEEN-NEEDLE SYSTEM
K893647 COPOLYESTER FILM DRESSING
Search all 16 clearances from Tri-State Hospital Supply Corp. →