FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGI ACUPUNCTURE NEEDLES
K Number: K972658
·
Decision Oct 17, 1997
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
90
Applicant Total
2
Review Days
94
Basic Information
- Device Name
- MAGI ACUPUNCTURE NEEDLES
- K Number
- K972658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DONG BANG, U.S.A.
- Date Received
- July 15, 1997
- Decision Date
- October 17, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQX), ordered by most recent decision date.
AIK Sterile Acupuncture Needles for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
FDA 510(k)
FDA Class 2
·General Hospital
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
FDA 510(k)
FDA Class 2
·General Hospital
KM Needles (Acupuncture Needle)
FDA 510(k)
FDA Class 2
·General Hospital
SMC ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by DONG BANG, U.S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K972659 | DONG BANG ACUPUNCTURE NEEDLES | Oct 17, 1997 | Substantially Equivalent |