FDA 510(k)
Substantially Equivalent
🇺🇸 United States
GALTEL-18
K Number: K821850
·
Decision Jul 28, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
35
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Basic Information
- Device Name
- GALTEL-18
- K Number
- K821850
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Galvanic Medical Instruments, Inc.
- Date Received
- June 23, 1982
- Decision Date
- July 28, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Galvanic Medical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851318 | GUIBOR MICROELECTROLYSIS UNIT 18 | Aug 20, 1985 | Substantially Equivalent |