FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRCUMAURAL ADHESIVE REPLACEMENT
K Number: K111555
·
Decision Jul 25, 2011
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
4
Review Days
52
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Basic Information
- Device Name
- CIRCUMAURAL ADHESIVE REPLACEMENT
- K Number
- K111555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R & D Medical Products, Inc.
- Date Received
- June 3, 2011
- Decision Date
- July 25, 2011
- Product Code
- GWJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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