FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
K Number: K951064
·
Decision May 19, 1995
Classifications
1
FEI Numbers
398
Registration Numbers
398
Same Product Code
22
Applicant Total
1
Review Days
72
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Basic Information
- Device Name
- DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
- K Number
- K951064
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S-E Sales & Distribution, Inc.
- Date Received
- March 8, 1995
- Decision Date
- May 19, 1995
- Product Code
- FTY
- 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 |
|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | FDA class 1 | General, Plastic Surgery |
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