SERVOTRONIC EC100 SYSTEM
FDA 510(k) clearance K962087 · decided 1997-04-23
Clearance details
- K-number
- K962087
- Device name
- SERVOTRONIC EC100 SYSTEM
- Applicant
- Medicon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-28
- Decision date
- 1997-04-23
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- HWE
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.