FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUPUNCTURE NEEDLE PACK
K Number: K960769
·
Decision Jul 10, 1996
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
90
Applicant Total
5
Review Days
135
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Basic Information
- Device Name
- ACUPUNCTURE NEEDLE PACK
- K Number
- K960769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Acu-Med, Inc.
- Date Received
- February 26, 1996
- Decision Date
- July 10, 1996
- 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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Other Clearances by Acu-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960651 | CERCLAGE WIRE CRIMP BLOCK | May 3, 1996 | Substantially Equivalent |
| K952534 | TENTATIVELY POLARUS EX ROD | Jul 13, 1995 | Substantially Equivalent |
| K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM | Jun 26, 1992 | Substantially Equivalent |
| K910193 | HUENE FIXATION SCREW | Aug 23, 1991 | Substantially Equivalent for Some Indications |