510(k) K792608
K792608 is an FDA 510(k) premarket notification submitted by Aztec Medical Products, Inc. for the device "TEGTMEIER MAMMOMETER". The FDA issued a decision of Substantially Equivalent on January 4, 1980. Aztec Medical Products, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1980
- Date Received
- December 18, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No