FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMPRESAID
K Number: K881516
·
Decision Apr 29, 1988
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
6
Applicant Total
1
Review Days
18
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Basic Information
- Device Name
- COMPRESAID
- K Number
- K881516
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- R. Evans Corp.
- Date Received
- April 11, 1988
- Decision Date
- April 29, 1988
- Product Code
- FZF
- 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 |
|---|---|---|---|
| FZF | Splint, Extremity, Inflatable, External | FDA class 1 | General, Plastic Surgery |
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