510(k) K771569
K771569 is an FDA 510(k) premarket notification submitted by Tomtec for the device "AUTOSTREAKER". The FDA issued a decision of Substantially Equivalent on October 25, 1977. Tomtec has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1977
- Date Received
- August 15, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No