FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURELESS SKIN CLOSURE
K Number: K780565
·
Decision Jul 7, 1978
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
34
Applicant Total
883
Review Days
92
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Basic Information
- Device Name
- SUTURELESS SKIN CLOSURE
- K Number
- K780565
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- April 6, 1978
- Decision Date
- July 7, 1978
- Product Code
- FPX
- 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 |
|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPX), ordered by most recent decision date.
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BIOSTRIP STERILE WOUND CLOSURE STRIP
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DUKAL SKIN CLOSURE STRIP
FDA 510(k)
FDA Class 1
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SPYROFLEX WOUND CLOSURES
FDA 510(k)
FDA Class 1
·General Hospital
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