DISPOSABLE STORAGE CAP
FDA 510(k) clearance K010366 · decided 2001-11-28
Clearance details
- K-number
- K010366
- Device name
- DISPOSABLE STORAGE CAP
- Applicant
- Molded Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-07
- Decision date
- 2001-11-28
- Days to decision
- 294 days
- Clearance type
- Abbreviated
- Product code
- FJI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harlan, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.