FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
K Number: K943740
·
Decision Dec 14, 1994
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
9
Review Days
134
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Basic Information
- Device Name
- ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
- K Number
- K943740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Premium Plastics, Inc.
- Date Received
- August 2, 1994
- Decision Date
- December 14, 1994
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Premium Plastics, Inc.
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|---|---|---|---|
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| K950850 | GENT-L-KARE LACERATION TRAYS | Mar 14, 1995 | Substantially Equivalent for Some Indications |
| K890107 | GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT | Oct 24, 1989 | Unknown |
| K893135 | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER | Jun 22, 1989 | Substantially Equivalent |
| K850285 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY | Feb 28, 1985 | Substantially Equivalent |
| K800440 | STERILE SPONGE BOWLS | Apr 29, 1980 | Substantially Equivalent |
| K771448 | STERILE SUTURE REMOVAL KIT | Sep 6, 1977 | Substantially Equivalent |