FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUARTZ RODS TITANIUM RODS
K Number: K862472
·
Decision Sep 12, 1986
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
74
Basic Information
- Device Name
- QUARTZ RODS TITANIUM RODS
- K Number
- K862472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- QUALI-MED, INC.
- Date Received
- June 30, 1986
- Decision Date
- September 12, 1986
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by QUALI-MED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K871408 | BLOOD VESSEL CONNECTOR | Apr 27, 1987 | Substantially Equivalent |
| K862972 | DISPOSABLE MIRROR | Sep 23, 1986 | Substantially Equivalent |
| K862241 | STANDARD BASIN KIT CUSTOM BASIN KIT | Aug 1, 1986 | Substantially Equivalent |
| K862242 | PAP SMEAR KIT | Jun 26, 1986 | Substantially Equivalent |
| K862172 | QUALI-MED'S OPERATING ROOM DRAPES | Jun 19, 1986 | Substantially Equivalent |
| K861198 | CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) | May 16, 1986 | Unknown |