FDA 510(k)
Substantially Equivalent for Some Indications
🇺🇸 United States
SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
K Number: K852180
·
Decision Jul 1, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
42
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Basic Information
- Device Name
- SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
- K Number
- K852180
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Surgidyne, Inc.
- Date Received
- May 20, 1985
- Decision Date
- July 1, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Surgidyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892334 | LEONARD TUBE | May 31, 1989 | Substantially Equivalent |
| K883582 | VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM | Oct 3, 1988 | Substantially Equivalent |
| K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Jan 15, 1987 | Substantially Equivalent |
| K860030 | SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID | Feb 12, 1986 | Substantially Equivalent |
| K850634 | SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS | Jun 28, 1985 | Substantially Equivalent |