FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SNAP STERNUM SAW
K Number: K935517
·
Decision Mar 10, 1994
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
1
Applicant Total
5
Review Days
112
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Basic Information
- Device Name
- SNAP STERNUM SAW
- K Number
- K935517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgiquip, Inc.
- Date Received
- November 18, 1993
- Decision Date
- March 10, 1994
- Product Code
- HAB
- 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 |
|---|---|---|---|
| HAB | Saw, Powered, And Accessories | FDA class 1 | General, Plastic Surgery |
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