FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEIRIN PYONEX ACUPUNCTURE NEEDLES
K Number: K970254
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
90
Applicant Total
4
Review Days
19
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Basic Information
- Device Name
- SEIRIN PYONEX ACUPUNCTURE NEEDLES
- K Number
- K970254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seirin-America, Inc.
- Date Received
- January 22, 1997
- Decision Date
- February 10, 1997
- 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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