FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUE FLOW(TM) VALVE
K Number: K930611
·
Decision Dec 1, 1993
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
11
Review Days
299
Basic Information
- Device Name
- TRUE FLOW(TM) VALVE
- K Number
- K930611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GM ENGINEERING, INC.
- Date Received
- February 5, 1993
- Decision Date
- December 1, 1993
- 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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|---|---|---|---|
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| K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT | Jul 20, 1994 | Substantially Equivalent |
| K941660 | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT | May 24, 1994 | Substantially Equivalent |
| K933962 | GM CONTINUOUS FLOW BIOPSY PROBE | Feb 25, 1994 | Substantially Equivalent |
| K934035 | GM MONOPOLAR/FRAZIER SUCTION PROBE | Dec 1, 1993 | Substantially Equivalent |
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