510(k) K082750
- Device
- ENTACT SEPTAL STAPLER, MODEL 610-00100
- Applicant
- ENTRIGUE SURGICAL, INC.
- 510(k) number
- K082750
- Product code
- OLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-06
- Date received
- 2008-09-19
- Regulation
- 878.4750
- Classification name
- Septal Stapler/absorbable Staples
- Medical specialty
- General & Plastic Surgery
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GABRIELE G NIEDERAUER
- Address
- 12672 Silicon Dr. Suite 150 San Antonio TX US 78249 78249
FDA Registration Numbers#
- 1058584
- 1423662
- 1643264
- 2011171
- 3006524618
- 3006891611
- 2029275
- 1649518
Source Documents#
Legacy Summary#
summary
FDA Review#
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