510(k) K013987
- Device
- REPROCESSED DISPOSABLE TROCARS
- Applicant
- ADVEN MEDICAL
- 510(k) number
- K013987
- Product code
- KBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-01
- Date received
- 2001-12-04
- Regulation
- 874.4420
- Classification name
- Trocar, Sinus
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK W ALDANA
- Address
- 1001 Slaton Hwy. Lubbock TX US 79404 79404
FDA Registration Numbers#
- 3023657851
- 9616250
- 8043746
- 3005067367
- 1836161
- 8040278
- 3008902714
- 3014615697
- 1057946
- 3009822485
- 3015398570
- 9612075
- 9611283
- 9613926
- 2529846
- 3003882387
- 1926681
- 3004608878
- 9610905
- 8030607
- 3003244954
- 3003418325
- 9610612
- 3036795921
Source Documents#
Other 510(k) Records For Product Code KBG #
Legacy Summary#
summary
FDA Review#
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