510(k) K844458
K844458 is an FDA 510(k) premarket notification submitted by Endo Lase, Inc. for the device "ND:YAG LASER PULMONARY OBSTRUCTION". The FDA issued a decision of Substantially Equivalent on January 3, 1985. Endo Lase, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1985
- Date Received
- November 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No