FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MANIPLER DISPOSABLE SKIN STAPLER
K Number: K925526
·
Decision Jun 24, 1993
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
18
Applicant Total
1
Review Days
234
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Basic Information
- Device Name
- MANIPLER DISPOSABLE SKIN STAPLER
- K Number
- K925526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4760
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Matsutani Seisakusho Co. , Ltd.
- Date Received
- November 2, 1992
- Decision Date
- June 24, 1993
- Product Code
- GDT
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GDT | Staple, Removable (Skin) | FDA class 1 | General, Plastic Surgery |
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