510(k) K853623
K853623 is an FDA 510(k) premarket notification submitted by Co-Medical, Inc. for the device "CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N". The FDA issued a decision of Substantially Equivalent on Oct 8, 1985. Co-Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 8, 1985
- Date Received
- Aug 29, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No