STORZ MODEL 62 ENT CAMERA SYSTEM
FDA 510(k) clearance K883760 · decided 1988-09-28
Clearance details
- K-number
- K883760
- Device name
- STORZ MODEL 62 ENT CAMERA SYSTEM
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-06
- Decision date
- 1988-09-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FWL
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, 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 |
|---|---|---|
| WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K951519) | Wells Johnson Co. | 1995-06-14 |
Recalls involving this device
No recalls on record reference this clearance.