LANCASTER COOLING JACKET, CAT. CODE #13500/13501
FDA 510(k) clearance K913077 · decided 1992-01-09
Clearance details
- K-number
- K913077
- Device name
- LANCASTER COOLING JACKET, CAT. CODE #13500/13501
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-11
- Decision date
- 1992-01-09
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.