510(k) K812052
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