510(k) K912839
- Device
- Laparooptx(tm) Intraoper Deflect Choledochoscope
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K912839
- Product code
- FBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-25
- Date received
- 1991-06-26
- Regulation
- 876.5520
- Classification name
- Filiform And Filiform Follower
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLE E MARCOT
- Address
- 2132 Michelson Dr. Irvine CA US 92715 92715
FDA Registration Numbers#
- 3004365956
- 1018233
- 9617592
- 1313046
- 8040278
- 1820334
- 9616250
- 9616067
- 3006082230
- 3035708926
- 1825146
- 3011137372
Source Documents#
510(k) summary PDF not indicated by FDA