510(k) K902119
K902119 is an FDA 510(k) premarket notification submitted by Kedumin Kits, Ltd. for the device "SAFEBRIS STERILE CIRCUMCISION KIT". The FDA issued a decision of Substantially Equivalent on November 5, 1990. The device falls under product code FHJ (Shield, Circumcision), a Class II device regulated under 21 CFR 884.4530.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1990
- Date Received
- May 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Circumcision
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type