510(k) K842359
K842359 is an FDA 510(k) premarket notification submitted by Planmeca USA, Inc. for the device "AUTOMATIC PATIENT CHAIR PM2000 & A". The FDA issued a decision of Substantially Equivalent on September 19, 1984. Planmeca USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1984
- Date Received
- June 22, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No