FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
K Number: K844199
·
Decision Nov 7, 1984
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
17
Review Days
8
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Basic Information
- Device Name
- ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
- K Number
- K844199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kleen Test Products
- Date Received
- October 30, 1984
- Decision Date
- November 7, 1984
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 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 |
| K890539 | SURE COUNT LIGHT HANDLE COVER | Feb 27, 1989 | Substantially Equivalent |
| K890098 | KLEEN TEST O.R. KIT | Jan 24, 1989 | Substantially Equivalent |
| K853622 | SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 | Oct 10, 1985 | Substantially Equivalent |
| 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 |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | Jun 9, 1982 | Substantially Equivalent |
| K821394 | SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER | Jun 3, 1982 | Substantially Equivalent |