FDA 510(k)
Substantially Equivalent
🇺🇸 United States
5X2 SATALEC CHIROPODY CASE
K Number: K853200
·
Decision Oct 18, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
126
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Basic Information
- Device Name
- 5X2 SATALEC CHIROPODY CASE
- K Number
- K853200
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Spelna, Inc.
- Date Received
- June 14, 1985
- Decision Date
- October 18, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Spelna, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852525 | SATALEC PIEZOTEC | Jan 30, 1986 | Substantially Equivalent |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | Jan 3, 1986 | Substantially Equivalent |
| K852522 | SATALEC SERVOTOME | Dec 27, 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 |