BARD EAGLE INFLATION DEVICE
FDA 510(k) clearance K962611 · decided 1996-10-21
Clearance details
- K-number
- K962611
- Device name
- BARD EAGLE INFLATION DEVICE
- Applicant
- Ryder Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-03
- Decision date
- 1996-10-21
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- KOE
- Device class
- 2
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Arab, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.