STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
FDA 510(k) clearance K001082 · decided 2000-06-15
Clearance details
- K-number
- K001082
- Device name
- STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
- Applicant
- Stackhouse, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-04
- Decision date
- 2000-06-15
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FYD
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palm Spring, CA, US
- Third-party review
- No
- Expedited review
- No
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