S 21 INSTRUMENT STAND
FDA 510(k) clearance K883578 · decided 1988-09-13
Clearance details
- K-number
- K883578
- Device name
- S 21 INSTRUMENT STAND
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-22
- Decision date
- 1988-09-13
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FSH
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Thornwood, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| S 4 INSTRUMENT STAND (K884876) | Carl Zeiss, Inc. | 1988-12-15 |
| STAND, SURG. INSTRUMENT & DRESSING (K821921) | Emerson-Sack-Warner Corp. | 1982-07-30 |
| SKINNY CHIBA NEEDLE & TRAY (K813337) | American Pharmaseal Div. Ahsc | 1982-01-28 |
| BIOPSY NEEDLES & TRAYS (K813338) | American Pharmaseal Div. Ahsc | 1982-01-28 |
| PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY (K813335) | American Pharmaseal Div. Ahsc | 1982-01-08 |
| MODEL 902 STAND (K780759) | Applied Medical Research | 1978-05-19 |
| FSH RIA KIT (125I) (K772188) | Diagnostic Products Corp. | 1977-12-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |