FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURE COUNT LIGHT HANDLE COVER
K Number: K890539
·
Decision Feb 27, 1989
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
25
Applicant Total
17
Review Days
24
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Basic Information
- Device Name
- SURE COUNT LIGHT HANDLE COVER
- K Number
- K890539
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kleen Test Products
- Date Received
- February 3, 1989
- Decision Date
- February 27, 1989
- Product Code
- FTA
- 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 |
|---|---|---|---|
| FTA | Light, Surgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kleen Test Products
| K Number | Device Name | ||
|---|---|---|---|
| K890039 | KLEEN TEST BASIN SET | Oct 24, 1989 | Substantially Equivalent |
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| K853454 | SURE COUNT 5 & 10 SPONGE COUNTER | Sep 5, 1985 | Substantially Equivalent |
| K853315 | CAUTERY TIP CLEANING PAD | Aug 21, 1985 | Substantially Equivalent |
| K852258 | SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER | Jun 27, 1985 | Substantially Equivalent |
| K852257 | SURE-COUNT 15 COUNT NEEDLE COUNTER | Jun 26, 1985 | Substantially Equivalent |
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | Nov 7, 1984 | Substantially Equivalent |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | Jun 9, 1982 | Substantially Equivalent |
| K821394 | SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER | Jun 3, 1982 | Substantially Equivalent |