EXTERNAL PACEMAKER WIRE DRESSING CHANGE
FDA 510(k) clearance K881356 · decided 1988-05-19
Clearance details
- K-number
- K881356
- Device name
- EXTERNAL PACEMAKER WIRE DRESSING CHANGE
- Applicant
- Neal & Assoc., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-28
- Decision date
- 1988-05-19
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Columbia, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.