FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
READY NURSE SYSTEM (RNS) TRACH CARE KIT
K Number: K952925
·
Decision Jul 12, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
5
Applicant Total
18
Review Days
16
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Basic Information
- Device Name
- READY NURSE SYSTEM (RNS) TRACH CARE KIT
- K Number
- K952925
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Contour Fabricators of Florida, Inc.
- Date Received
- June 26, 1995
- Decision Date
- July 12, 1995
- Product Code
- LRQ
- 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 |
|---|---|---|---|
| LRQ | Tracheostomy And Nasal Suctioning Kit | FDA class 1 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRQ), ordered by most recent decision date.
TRACHEOSTOMY KIT
FDA 510(k)
FDA Class 1
·Unknown
MEDCARE TRACHEOSTOMY CARE TRAY
FDA 510(k)
FDA Class 1
·Unknown
GENT-L-KARE TRACHEOSTOMY TRAYS
FDA 510(k)
FDA Class 1
·Unknown
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
FDA 510(k)
FDA Class 1
·Unknown
TRACHEOSTOMY CARE TRAY
FDA 510(k)
FDA Class 1
·Unknown
Other Clearances by Contour Fabricators of Florida, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955685 | RNS STERILE, DISPOSABLE CT BIOPSY TRAY | Oct 4, 1996 | Substantially Equivalent |
| K962040 | RNS ARTHROGRAM TRAY | Jun 25, 1996 | Substantially Equivalent |
| K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | Jun 3, 1996 | Substantially Equivalent |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | May 15, 1996 | Substantially Equivalent |
| K955684 | RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY | May 2, 1996 | Unknown |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Mar 12, 1996 | Substantially Equivalent |
| K955688 | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY | Feb 21, 1996 | Substantially Equivalent |
| K955686 | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | Feb 21, 1996 | Substantially Equivalent |
| K955678 | RNS STERILE DISPOSABLE PUNCTURE TRAY | Feb 21, 1996 | Substantially Equivalent |
| K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | Feb 1, 1996 | Substantially Equivalent |