FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDICAL TAPE (MULTIPLE)
K Number: K813364
·
Decision Jan 19, 1982
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
7
Review Days
50
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Basic Information
- Device Name
- MEDICAL TAPE (MULTIPLE)
- K Number
- K813364
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cederroth, Inc. USA
- Date Received
- November 30, 1981
- Decision Date
- January 19, 1982
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
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PARALLEL
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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 |
| K813365 | MULTIPLE BANDAGE OR DRESSING | Feb 4, 1982 | Substantially Equivalent |
| K813361 | ADHESIVE STRIP(MULTIPLE) | Jan 18, 1982 | Substantially Equivalent |