PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
FDA 510(k) clearance K050112 · decided 2005-03-15
Clearance details
- K-number
- K050112
- Device name
- PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
- Applicant
- Prime Pacific Health Innovations Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-01-18
- Decision date
- 2005-03-15
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- North Vancouver, Bc, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.