FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLOR CODING OF SURGICAL INSTRUMENTS
K Number: K790684
·
Decision May 18, 1979
Classifications
1
FEI Numbers
251
Registration Numbers
251
Same Product Code
51
Applicant Total
2
Review Days
37
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Basic Information
- Device Name
- COLOR CODING OF SURGICAL INSTRUMENTS
- K Number
- K790684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sara Dan, Inc.
- Date Received
- April 11, 1979
- Decision Date
- May 18, 1979
- 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 |
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Other Clearances by Sara Dan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K792600 | MODEL III HANDSWITCH | Jan 10, 1980 | Substantially Equivalent |