FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
K Number: K931748
·
Decision Feb 25, 1994
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
16
Review Days
323
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Basic Information
- Device Name
- CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
- K Number
- K931748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Tri-State Hospital Supply Corp.
- Date Received
- April 8, 1993
- Decision Date
- February 25, 1994
- Product Code
- LJT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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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 |
| K945977 | CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING | Mar 29, 1995 | Substantially Equivalent |
| 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 |