FDA 510(k)
Substantially Equivalent
🇺🇸 United States
EXTERNAL MECHANICAL FASTENER
K Number: K854068
·
Decision Nov 22, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
15
Review Days
49
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Basic Information
- Device Name
- EXTERNAL MECHANICAL FASTENER
- K Number
- K854068
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Wells Johnson Co.
- Date Received
- October 4, 1985
- Decision Date
- November 22, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K971580 | UAS ULTRASONIC ASPIRATOR SYSTEM | Dec 9, 1997 | Substantially Equivalent |
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Dec 4, 1995 | Substantially Equivalent |
| K945500 | WELLS JOHNSON FIXATION SYSTEM | Sep 21, 1995 | Substantially Equivalent |
| K951519 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Jun 14, 1995 | Substantially Equivalent |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Mar 2, 1995 | Substantially Equivalent |
| K945805 | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE | Dec 13, 1994 | Substantially Equivalent |
| K843188 | WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP | Sep 20, 1984 | Substantially Equivalent |
| K832520 | SUCTION TIPS | Oct 20, 1983 | Substantially Equivalent |