FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BIOMATE STERILE ACUPUNCTURE NEEDLE
K Number: K103061
·
Decision Jun 20, 2011
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
90
Applicant Total
3
Review Days
245
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Basic Information
- Device Name
- BIOMATE STERILE ACUPUNCTURE NEEDLE
- K Number
- K103061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomate Medical Devices Technology Co., Ltd.
- Date Received
- October 18, 2010
- Decision Date
- June 20, 2011
- Product Code
- MQX
- 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 |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | FDA class 2 | General Hospital |
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