FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SATALEC SEPTOSONIC SC 80/SC 120
K Number: K852527
·
Decision Jan 3, 1986
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
18
Applicant Total
11
Review Days
203
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Basic Information
- Device Name
- SATALEC SEPTOSONIC SC 80/SC 120
- K Number
- K852527
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Spelna, Inc.
- Date Received
- June 14, 1985
- Decision Date
- January 3, 1986
- Product Code
- FLG
- 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 |
|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | FDA class 1 | General Hospital |
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Other Clearances by Spelna, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852525 | SATALEC PIEZOTEC | Jan 30, 1986 | Substantially Equivalent |
| K852522 | SATALEC SERVOTOME | Dec 27, 1985 | Substantially Equivalent |
| K853200 | 5X2 SATALEC CHIROPODY CASE | Oct 18, 1985 | Substantially Equivalent |
| K852524 | SATALEC SERVOTORQUE S2 SX2 | Jul 31, 1985 | Substantially Equivalent |
| K852521 | SATLEC PROPHY UNIT PU 3055 | Jul 31, 1985 | Substantially Equivalent |
| K832674 | SATELEC PROPHY UNIT PU 2000S | Mar 16, 1984 | Substantially Equivalent |
| K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | Mar 16, 1984 | Substantially Equivalent |
| K832673 | SATELEC PROPHY UNIT PU-2000 | Oct 19, 1983 | Substantially Equivalent |
| K832665 | SATELEC SUPRASSON SP 3055 | Oct 19, 1983 | Substantially Equivalent |
| K820256 | MEDILAC #SR4 & SR 40 | Jun 25, 1982 | Substantially Equivalent |