ENTACT SEPTAL STAPLER, MODEL 610-00100
FDA 510(k) clearance K082750 · decided 2009-01-06
Clearance details
- K-number
- K082750
- Device name
- ENTACT SEPTAL STAPLER, MODEL 610-00100
- Applicant
- Entrigue Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-19
- Decision date
- 2009-01-06
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- OLL
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.