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 | Device Class | Medical Specialty |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGP), ordered by most recent decision date.
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LASERSKIN DRESSING
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FASTSEAL CHEST WOUND DRESSING
FDA 510(k)
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SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
FDA Unclassified
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DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Tri-State Hospital Supply Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Aug 28, 2008 | Substantially Equivalent |
| K080524 | CENTURION SORBAVIEW OTC | Apr 23, 2008 | Substantially Equivalent |
| K942353 | CENTURION UMBILICAL CATHETER | Aug 15, 1995 | Substantially Equivalent |
| K931748 | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS | Feb 25, 1994 | Unknown |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | Feb 17, 1994 | Substantially Equivalent |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | Dec 17, 1992 | Substantially Equivalent |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | Apr 1, 1991 | Substantially Equivalent |
| K897100 | CENTURION VAGINAL SPECULUM | Mar 16, 1990 | Substantially Equivalent |
| K896320 | CENTURION KLEEN-NEEDLE SYSTEM | Jan 11, 1990 | Substantially Equivalent |
| K893647 | COPOLYESTER FILM DRESSING | Oct 16, 1989 | Substantially Equivalent |