FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030
K Number: K853622
·
Decision Oct 10, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
17
Review Days
42
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Basic Information
- Device Name
- SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030
- K Number
- K853622
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Kleen Test Products
- Date Received
- August 29, 1985
- Decision Date
- October 10, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Kleen Test Products
| K Number | Device Name | ||
|---|---|---|---|
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| K890098 | KLEEN TEST O.R. KIT | Jan 24, 1989 | 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 |
| 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 |