HEMATOME SYSTEM
FDA 510(k) clearance K885066 · decided 1989-05-01
Clearance details
- K-number
- K885066
- Device name
- HEMATOME SYSTEM
- Applicant
- Surgical Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-06
- Decision date
- 1989-05-01
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- GET
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Leandro, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.