FOLEY-TEMP(TM)
FDA 510(k) clearance K882130 · decided 1988-08-09
Clearance details
- K-number
- K882130
- Device name
- FOLEY-TEMP(TM)
- Applicant
- Mallinckroot, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-20
- Decision date
- 1988-08-09
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- EYB
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Argyle, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.