510(k) K831229
K831229 is an FDA 510(k) premarket notification submitted by Shofu Dental Corp. for the device "SUPER SNAPS". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code FHJ (Shield, Circumcision), a Class II device regulated under 21 CFR 884.4530. Shofu Dental Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1983
- Date Received
- April 15, 1983
- 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