510(k) K915837
- Device
- NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM
- Applicant
- C.R. Bard, Inc.
- 510(k) number
- K915837
- Product code
- KNT
- Decision
- Unknown (SESK)
- Decision date
- 1993-03-23
- Date received
- 1991-12-24
- Regulation
- 876.5980
- Classification name
- Tubes, Gastrointestinal (And Accessories)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- ROWLAND WILLIAMS
- Address
- 111 Spring St. Murray Hill NJ US 07974 07974
FDA Registration Numbers
- 3005670221
- 1423662
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Source Documents
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