FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL STITCH CUTTER
K Number: K800103
·
Decision Jan 28, 1980
Classifications
1
FEI Numbers
251
Registration Numbers
251
Same Product Code
51
Applicant Total
2
Review Days
12
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Basic Information
- Device Name
- SURGICAL STITCH CUTTER
- K Number
- K800103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Macon & Co., Inc.
- Date Received
- January 16, 1980
- Decision Date
- January 28, 1980
- Product Code
- FZT
- 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 |
|---|---|---|---|
| FZT | Cutter, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZT), ordered by most recent decision date.
SMARTSHEARS
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MICRINS SURGICAL SCISSOR
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SCISSORS, VARIOUS
FDA 510(k)
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Other Clearances by Macon & Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902802 | FETAL MONITORING TRANSDUCER STRAP | Sep 4, 1990 | Substantially Equivalent |