510(k) K812052

MYOCATH CATOLOG NO. MCK-A by Sorensen Research

K812052 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "MYOCATH CATOLOG NO. MCK-A". The FDA issued a decision of Substantially Equivalent on October 6, 1981. Sorensen Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No