ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
FDA 510(k) clearance K022480 · decided 2002-08-22
Clearance details
- K-number
- K022480
- Device name
- ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
- Applicant
- Acmi Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-07-26
- Decision date
- 2002-08-22
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.