FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
S 21 INSTRUMENT STAND
K Number: K883578
·
Decision Sep 13, 1988
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
7
Applicant Total
44
Review Days
22
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Basic Information
- Device Name
- S 21 INSTRUMENT STAND
- K Number
- K883578
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Carl Zeiss, Inc.
- Date Received
- August 22, 1988
- Decision Date
- September 13, 1988
- Product Code
- FSH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FSH | Tray, Surgical, Needle | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSH), ordered by most recent decision date.
S 4 INSTRUMENT STAND
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Other Clearances by Carl Zeiss, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013402 | VISULAS 532S | Nov 14, 2001 | Substantially Equivalent |
| K003885 | VISULAS YAG II | Feb 22, 2001 | Substantially Equivalent |
| K993357 | IOLMASTER | Mar 20, 2000 | Substantially Equivalent |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Jan 29, 1999 | Substantially Equivalent |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K961380 | CPC PROBE | Mar 17, 1997 | Substantially Equivalent |
| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent |
| K952894 | VISULINK 900 ARGON | Aug 14, 1995 | Substantially Equivalent |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |