SERIES 3 GENERAL SUCTION SYSTEM
FDA 510(k) clearance K891129 · decided 1989-09-25
Clearance details
- K-number
- K891129
- Device name
- SERIES 3 GENERAL SUCTION SYSTEM
- Applicant
- Ultravac, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-03
- Decision date
- 1989-09-25
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.