FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K Number: K935092
·
Decision Jun 10, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
18
Review Days
228
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Basic Information
- Device Name
- CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
- K Number
- K935092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Contour Fabricators of Florida, Inc.
- Date Received
- October 25, 1993
- Decision Date
- June 10, 1994
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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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 |