FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OUT-RITE WASTE DISPOSABLE BAG
K Number: K821396
·
Decision Jun 9, 1982
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
17
Review Days
29
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Basic Information
- Device Name
- OUT-RITE WASTE DISPOSABLE BAG
- K Number
- K821396
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Kleen Test Products
- Date Received
- May 11, 1982
- Decision Date
- June 9, 1982
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Similar 510(k) Clearances
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| 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 |
| K821394 | SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER | Jun 3, 1982 | Substantially Equivalent |