510(k) K112562
- Device
- BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
- Applicant
- KIMBERLY-CLARK
- 510(k) number
- K112562
- Product code
- OYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-15
- Date received
- 2011-09-26
- Regulation
- 868.6810
- Classification name
- Non-bronchoscopic Bronchoalveolar Lavage Catheter
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID LEE
- Address
- 1400 Holcomb Bridge Rd. Roswell GA US 30076 30076
FDA Registration Numbers#
- 3006950086
- 3030671648
- 3015225571
- 3012536737
- 3033589330
- 3011270181
- 1061124
- 1125782
- 1123137
- 1314417
- 3015309643
- 8030647
Source Documents#
Legacy Summary#
summary
FDA Review#
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