510(k) K864501
K864501 is an FDA 510(k) premarket notification submitted by Koken Mfg Company, Inc. for the device "KOKEN'S NEW MODEL M-3000 POWER TABLE". The FDA issued a decision of Substantially Equivalent on December 16, 1986. Koken Mfg Company, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1986
- Date Received
- November 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No