FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DERMAPIK
K Number: K882360
·
Decision Aug 9, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
24
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- DERMAPIK
- K Number
- K882360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Creative Scientific Equipment Corp.
- Date Received
- June 7, 1988
- Decision Date
- August 9, 1988
- Product Code
- SCL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| SCL | Allergen And Vaccine Delivery Needles | FDA class 2 | General Hospital |
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