510(k) K844462
K844462 is an FDA 510(k) premarket notification submitted by Washington-Greene County Branch Pennsylvania Assoc for the device "DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER". The FDA issued a decision of Substantially Equivalent on December 12, 1984. Washington-Greene County Branch Pennsylvania Assoc has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1984
- Date Received
- November 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No