WILSON-COOK PULL THROUGH PEG KIT
FDA 510(k) clearance K901163 · decided 1990-11-19
Clearance details
- K-number
- K901163
- Device name
- WILSON-COOK PULL THROUGH PEG KIT
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Unknown
- Date received
- 1990-03-13
- Decision date
- 1990-11-19
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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| MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700) | Benlan, Inc. | 2010-12-13 |
| GUARDIAN CONNECTION (K101214) | Maulin Medical, LLC | 2010-07-23 |
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| AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526) | Kentec Medical, Inc. | 2010-04-22 |
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Recalls involving this device
No recalls on record reference this clearance.