FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)
K Number: K963300
·
Decision Sep 23, 1996
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
90
Applicant Total
11
Review Days
33
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Basic Information
- Device Name
- DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)
- K Number
- K963300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lhasa Medical, Inc.
- Date Received
- August 21, 1996
- Decision Date
- September 23, 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 Lhasa Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | Jul 15, 2003 | Substantially Equivalent |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | Jul 11, 2003 | Substantially Equivalent |
| K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | Feb 14, 2003 | Substantially Equivalent |
| K013197 | WS-501 HEAT LAMP | Aug 29, 2002 | Substantially Equivalent |
| K003538 | TDP CQ-27 HEAT LAMP | Jun 4, 2001 | Substantially Equivalent |
| K003760 | TAI-CHI ACUPUNCTURE NEEDLES | Feb 6, 2001 | Substantially Equivalent |
| K964529 | CW ACUPUNCTURE NEEDLES | Jan 30, 1997 | Substantially Equivalent |
| K964411 | TAKI ACUPUNCTURE NEEDLES | Dec 31, 1996 | Substantially Equivalent |
| K963299 | HWA-TO ACUPUNCTURE NEEDLES | Sep 30, 1996 | Substantially Equivalent |
| K962916 | HUA-XIA ACUPUNCTURE NEEDLES | Aug 23, 1996 | Substantially Equivalent |