DILATING TIP OBTURATOR
FDA 510(k) clearance K012884 · decided 2002-01-17
Clearance details
- K-number
- K012884
- Device name
- DILATING TIP OBTURATOR
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-28
- Decision date
- 2002-01-17
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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