FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MULTIPLE BANDAGE OR DRESSING
K Number: K813365
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
7
Review Days
66
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Basic Information
- Device Name
- MULTIPLE BANDAGE OR DRESSING
- K Number
- K813365
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Cederroth, Inc. USA
- Date Received
- November 30, 1981
- Decision Date
- February 4, 1982
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Cederroth, Inc. USA
| K Number | Device Name | ||
|---|---|---|---|
| K880788 | NON ADHERENT PAD | Apr 1, 1988 | Substantially Equivalent for Some Indications |
| K823057 | MEDICATED ADHESIVE STRIP | Mar 31, 1983 | Substantially Equivalent |
| K830330 | SAVETT ALCOHOL PREP | Mar 17, 1983 | Substantially Equivalent |
| K820059 | RESUSCITATION MASK | Mar 26, 1982 | Substantially Equivalent |
| K813364 | MEDICAL TAPE (MULTIPLE) | Jan 19, 1982 | Substantially Equivalent |
| K813361 | ADHESIVE STRIP(MULTIPLE) | Jan 18, 1982 | Substantially Equivalent |