FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLEAN-CUFF
K Number: K952038
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
33
Applicant Total
7
Review Days
71
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Basic Information
- Device Name
- CLEAN-CUFF
- K Number
- K952038
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrumed, Inc.
- Date Received
- May 1, 1995
- Decision Date
- July 11, 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 Instrumed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940615 | ACCUTEST | May 19, 1995 | Substantially Equivalent |
| K924273 | ACCUFLATE | Jan 12, 1993 | Substantially Equivalent |
| K924373 | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | Nov 25, 1992 | Substantially Equivalent |
| K910512 | ACCUFLATE | Feb 19, 1991 | Substantially Equivalent |
| K890014 | DISPOSABLE COLOR-CUFFS | Jan 24, 1989 | Substantially Equivalent |
| K860617 | POLYPET | Mar 3, 1986 | Substantially Equivalent |