510(k) K822740
K822740 is an FDA 510(k) premarket notification submitted by Kaycor Intl., Ltd. for the device "K30000 DENTAL CHAIR". The FDA issued a decision of Substantially Equivalent on September 28, 1982. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Kaycor Intl., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1982
- Date Received
- September 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Dental, With Operative Unit
- Device Class
- Class I
- Regulation Number
- 872.6250
- Review Panel
- DE
- Submission Type