DOBBHOFF(R) SINGLE PASS PEG KIT
FDA 510(k) clearance K913784 · decided 1992-01-15
Clearance details
- K-number
- K913784
- Device name
- DOBBHOFF(R) SINGLE PASS PEG KIT
- Applicant
- Biosearch Medical Products, Inc.
- Decision
- Unknown
- Date received
- 1991-08-23
- Decision date
- 1992-01-15
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.