FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BUONAFEDE PNEUMATIC SLEEVE
K Number: K954201
·
Decision Nov 9, 1995
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
33
Applicant Total
16
Review Days
64
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Basic Information
- Device Name
- BUONAFEDE PNEUMATIC SLEEVE
- K Number
- K954201
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedic, Inc.
- Date Received
- September 6, 1995
- Decision Date
- November 9, 1995
- Product Code
- KCY
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KCY | Tourniquet, Pneumatic | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Promedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131889 | EUM 100PRO | Apr 23, 2014 | Substantially Equivalent |
| K112318 | CLEARPATH 24 | Jun 29, 2012 | Substantially Equivalent |
| K072756 | NON-IV ADAPTER FOR INFANT NG TUBE | Dec 19, 2007 | Unknown |
| K060497 | BABYAIR | Jul 11, 2006 | Substantially Equivalent |
| K060842 | REVJET TURBO | Jun 21, 2006 | Substantially Equivalent |
| K052903 | PEDIATRIC FEEDING TUBE | Nov 9, 2005 | Substantially Equivalent |
| K031409 | URINARY CATHETERS | Jun 17, 2003 | Substantially Equivalent |
| K024190 | FENESTRATED INFUSION CATHETER | Mar 17, 2003 | Substantially Equivalent |
| K023579 | GAS SAMPLING LINES | Jan 28, 2003 | Substantially Equivalent |
| K020005 | INFANT FEEDING TUBES | Jul 16, 2002 | Substantially Equivalent |