510(k) K844458

ND:YAG LASER PULMONARY OBSTRUCTION by Endo Lase, Inc.

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