510(k) K010450
- Device
- LIVER TAMPONADE BALLOON
- Applicant
- COOK, INC.
- 510(k) number
- K010450
- Product code
- NGU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-06
- Date received
- 2001-02-15
- Regulation
- 876.5980
- Classification name
- Balloon, Liver Tamponade
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA HOPKINS
- Address
- 925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402
Source Documents#
Legacy Summary#
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FDA Review#
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