510(k) K884290
K884290 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER DISPOSABLE CIRCUMCISION TRAY". The FDA issued a decision of Substantially Equivalent with Drug on Dec 8, 1988. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESD (Substantially Equivalent with Drug)
- Decision Date
- Dec 8, 1988
- Date Received
- Oct 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Clamp, Circumcision
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k)