510(k) K851164
K851164 is an FDA 510(k) premarket notification submitted by Orion Corp. for the device "DENTOCULT CULTURE-PADDLE". The FDA issued a decision of Substantially Equivalent on October 29, 1985. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Orion Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1985
- Date Received
- March 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter (Beta, Gamma) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2320
- Review Panel
- CH
- Submission Type