510(k) K912839
K912839 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE". The FDA issued a decision of Substantially Equivalent on Sep 25, 1991. The device falls under product code FBW (Filiform And Filiform Follower), a Class I device regulated under 21 CFR 876.5520. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 1991
- Date Received
- Jun 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Filiform And Filiform Follower
- Device Class
- Class I
- Regulation Number
- 876.5520
- Review Panel
- GU
- Submission Type
- 510(k) Exempt