510(k) K801386
K801386 is an FDA 510(k) premarket notification submitted by Pre-Dent System for the device "PRE-DENT SYSTEM OR PRE-DENT II". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code KSS (Supplies, Blood-Bank), a Class I device regulated under 21 CFR 864.9050. Pre-Dent System has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1980
- Date Received
- June 13, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Supplies, Blood-Bank
- Device Class
- Class I
- Regulation Number
- 864.9050
- Review Panel
- HE
- Submission Type