FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTI-FOG DISPOSABLE IV INDUCTION COVER
K Number: K910104
·
Decision Apr 12, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
2
Review Days
99
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Basic Information
- Device Name
- ANTI-FOG DISPOSABLE IV INDUCTION COVER
- K Number
- K910104
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Central Plastic, Inc.
- Date Received
- January 3, 1991
- Decision Date
- April 12, 1991
- Product Code
- EYF
- 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 |
|---|---|---|---|
| EYF | Protector, Wound, Plastic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EYF), ordered by most recent decision date.
IRRIVAGE
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SI-PRO
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COMFEEL PROTECTIVE RINGS
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Other Clearances by Central Plastic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894427 | DISPOSABLE IV INDUCTION COVER | Sep 11, 1989 | Substantially Equivalent |