STORZ MILLENNIUM VISCOUS FLUID SYSTEM
FDA 510(k) clearance K972664 · decided 1997-10-10
Clearance details
- K-number
- K972664
- Device name
- STORZ MILLENNIUM VISCOUS FLUID SYSTEM
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-16
- Decision date
- 1997-10-10
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- MRH
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.