PRG BUTTON
FDA 510(k) clearance K946140 · decided 1995-08-28
Clearance details
- K-number
- K946140
- Device name
- PRG BUTTON
- Applicant
- Applied Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1994-12-16
- Decision date
- 1995-08-28
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Independence, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.