STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
FDA 510(k) clearance K954726 · decided 1995-11-29
Clearance details
- K-number
- K954726
- Device name
- STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1995-08-03
- Decision date
- 1995-11-29
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- GCX
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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